Page Range | 31976-32002 | |
FR Document | 2017-14453 |
[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)] [Notices] [Pages 31976-32002] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14453] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1129] Medical Devices; Exemptions From Premarket Notification: Class II Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued a notice proposing to exempt a list of class II devices from the premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject to certain limitations. This notice was issued in accordance with the 21st Century Cures Act (Pub. L. 114-255), which was signed into law on December 13, 2016. Section 3054 of that statute amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the 21st Century Cures Act and at least once every 5 years thereafter, FDA must publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act (generally referred to as a premarket notification or ``510(k)'') to provide reasonable assurance of safety and effectiveness. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the Federal Register a list representing its final determination regarding the list of devices proposed in the March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that upon the date that this final list is published in the Federal Register, a 510(k) will no longer be required for the listed devices and the applicable classification regulation for these devices shall be deemed amended to incorporate such exemption. Interested persons were given until May 15, 2017, to comment on the proposed list of class II devices. After reviewing these comments and considering whether the proposed list should be modified, FDA is now identifying its final determination as to which of those devices are now exempt from premarket notification requirements, subject to certain limitations, as indicated in tables 1 to 3 of this notice. In a future action, FDA intends to amend the codified language for each listed device's classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should withdraw their submissions. These exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review. II. Criteria for Exemption There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled ``Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k) Exemption Guidance'') (Ref. 1). [[Page 31977]] III. Limitations on Exemptions FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide. In addition to being subject to the general limitations to the exemptions found in Title 21 of the Code of Federal Regulations (CFR) sections 862.9 to 892.9 (Sec. Sec. 862.9 to 892.9), when Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices in a particular group, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. Partial exemption limitations can be found in table 2 of this notice. FDA has assigned new product codes to the device types that are now exempt subject to the partial limitations in order to ensure that these devices can be separated from devices that do not fall within the partial exemption limitation under the existing product code (i.e., exempt and non-exempt devices within a device type will have distinct product codes). If table 2 indicates that a partial exemption limitation does apply to a device, then affected device manufacturers should review their registration and listing information to assess if they should list their device using the original classification product code, which requires premarket notification, or the new classification product code for the subset of that device type that is now 510(k) exempt (subject to the general limitations to the exemptions found in Sec. Sec. 862.9 to 892.9). In table 2, for example, FDA is listing the exemption of the tympanometer but limits the exemption to such devices that are in compliance with FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply with this partial exemption limitation and the corresponding general limitations in Sec. 874.9 are now exempt from the 510(k) requirements and should be identified under new product code ``PTP'' in subsequent registration and listing submissions. However, tympanometers not in compliance with each of these exemption limitations remain subject to the 510(k) requirements and will retain product code ``NAS.'' We recommend that device manufacturers document in their records any changes in the product code of their device with appropriate justification. IV. List of Class II Devices In table 1, FDA is identifying the following list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in Sec. Sec. 862.9 to 892.9: Table 1--Class II Devices ------------------------------------------------------------------------ 21 CFR section Device type Product code ------------------------------------------------------------------------ 862.1020.................. Acid Phosphatase, CJN Nitrophenylphosphate. 862.1020.................. Acid Phosphatase, Thymol CJR Blue Monophosphate. 862.1020.................. Acid Phosphatase, CJX Disodium Phenylphosphate. 862.1020.................. Acid Phosphatase, CKB Naphthyl Phosphate. 862.1020.................. Acid Phosphatase, CKE Thymolphthale Inmonophosphate. 862.1020.................. Acid Phosphatase, Beta CKH Glycerophosphate. 862.1020.................. Acid Phosphatase JFH (Prostatic), Tartrate Inhibited. 862.1090.................. Radioassay, Angiotensin KQN Converting Enzyme. 862.1100.................. Vanillin Pyruvate, AST/ CIF SGOT. 862.1100.................. Diazo, AST/SGOT.......... CIQ 862.1100.................. Hydrazone Colorimetry, CIS AST/SGOT. 862.1100.................. NADH Oxidation/NAD CIT Reduction, AST/SGOT. 862.1150.................. Calibrator, Primary...... JIS 862.1150.................. Calibrator, Secondary.... JIT 862.1150.................. Calibrator, Surrogate.... JIW 862.1150.................. Calibrator, Multi-Analyte JIX Mixture. 862.1345.................. Drink, Glucose Tolerance. MRV 862.1350.................. Continuous Glucose PJT Monitor Secondary Display. 862.1445.................. Chromatographic CEX Separation, Lactate Dehydrogenase Isoenzymes. 862.1445.................. Electrophoretic, Lactate CFE Dehydrogenase Isoenzymes. 862.1445.................. Differential Rate Kinetic JGF Method, Lactate Dehydrogenase Isoenzymes. 862.1509.................. System, Test, Urinary LPT Methylmalonic Acid. 862.1685.................. Radioimmunoassay, CEE Thyroxine-Binding Globulin. 862.1700.................. Radioimmunoassay, Total CDX Thyroxine. 862.1700.................. Enzyme Immunoassay, Non- KLI Radiolabeled, Total Thyroxine. 862.2265.................. High Throughput DNA PFF Sequence Analyzer. 862.2570.................. Instrumentation For NSU Clinical Multiplex Test Systems. 862.2570.................. Real Time Nucleic Acid OOI Amplification System. 862.2570.................. Mass Spectrometer For OTA Clinical Multiplex Test Systems. 862.2570.................. Micro Total Analysis OUE Instrument System. 862.2570.................. Complete Gene Expression OVA Profiling Accessory Reagents. 862.2570.................. DNA Genetic Analyzer..... PCA 862.2570.................. Data Acquisition Software PQQ 862.3200.................. Calibrators, Drug Mixture DKB 862.3200.................. Calibrators, Drug DLJ Specific. [[Page 31978]] 862.3200.................. Calibrators, Ethyl DNN Alcohol. 864.5400.................. Fibrometer............... GIE 864.5400.................. Timer, Coagulation....... JBT 864.5425.................. Control, Plasma, Abnormal GGC 864.5425.................. Plasma, Coagulation GGN Control. 864.5425.................. Plasma, Control, Normal.. GIZ 864.6550.................. Control, Fecal Occult OSL Blood. 864.6650.................. Study, Platelet Adhesive. JBZ 864.7275.................. Test, Euglobulin Lysis... JBO 864.7300.................. Fibrin Monomer JBN Paracoagulation. 864.7340.................. Fibrinogen Standard...... GFX 864.7340.................. Plasma, Fibrinogen GIL Control. 864.7375.................. Glutathione, Red-Cell.... GII 864.7375.................. Fluorescence, Visual JMH Observation (Qual., U.V.), Glutathione Reductase. 864.7375.................. Assay, Glutathione KQF Reductase. 864.7415.................. Control, Hemoglobin, JCM Abnormal. 864.7455.................. Stain, Fetal Hemoglobin.. GHQ 864.7500.................. Acid Hematin............. GGF 864.7720.................. Test, Prothrombin GGQ Consumption. 864.7735.................. Prothrombin-Proconvertin JPF and Thrombotest. 864.8150.................. Calibrator for Cell KRX Indices. 864.8165.................. Calibrator for Hemoglobin KRZ and Hematocrit Measurement. 864.8175.................. Calibrator for Platelet KRY Counting. 864.8185.................. Calibrator for Red-Cell KSA and White-Cell Counting. 864.8625.................. Standards and Controls, GFS Hemoglobin, Normal and Abnormal. 864.8625.................. Control, White-Cell...... GGL 864.8625.................. Control, Hemoglobin...... GGM 864.8625.................. Control, Platelet........ GJP 864.8625.................. Control, Red-Cell........ GJR 864.8625.................. Control, Hematocrit...... GLK 864.8625.................. Mixture, Control, White- GLQ Cell and Red-Cell Indices. 864.8625.................. Control, Cell Counter, JCN Normal and Abnormal. 864.8625.................. Mixture, Hematology JPK Quality Control. 864.8625.................. Material, Quality NRF Control, Semen Analysis. 864.8625.................. Control Material, Blood NRS Circulating Epithelial Cancer Cell. 864.9400.................. Solution, Stabilized KSK Enzyme. 866.3395.................. Norovirus Serological OUC Reagents. 866.5210.................. Immunochemical, CHN Ceruloplasmin. 866.5210.................. Ceruloplasmin, Rhodamine, DCT Antigen, Antiserum, Control. 866.5210.................. Ceruloplasmin, FITC, DCY Antigen, Antiserum, Control. 866.5210.................. Ceruloplasmin, Antigen, DDB Antiserum, Control. 866.5210.................. P-Phenyl-Enediamine/EDTA JFQ (Spectrophotometric), Ceruloplasmin. 866.5210.................. Indirect Copper Assay, JFR Ceruloplasmin. 866.5470.................. Hemoglobin, Chain DAM Specific, Antigen, Antiserum, Control. 866.5620.................. Alpha-2-Macroglobulin, DDT Rhodamine, Antigen, Antiserum, Control. 866.5620.................. Alpha-2-Macroglobulin, DDY FITC, Antigen, Antiserum, Control. 866.5620.................. Alpha-2-Macroglobulin, DEB Antigen, Antiserum, Control. 866.5630.................. System, Test, Beta-2- JZG Microglobulin Immunological. 866.5910.................. Quality Control Material, NZB Genetics, DNA. 868.1040.................. Algesimeter, Powered..... BSI 868.1400.................. Legging, Compression, Non- LLK Inflatable. 868.2500.................. Monitor, Oxygen, KLK Cutaneous, For Infant Not Under Gas Anesthesia. 868.2500.................. Monitor, Oxygen, LPP Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia. 868.2550.................. Pneumotachometer......... JAX 868.5180.................. Bed, Rocking, Breathing CCO Assist. 868.6250.................. Compressor, Air, Portable BTI 870.1390.................. Trocar................... DRC 870.1875.................. Lung Sound Monitor....... OCR 870.2675.................. Oscillometer............. DRZ 870.4280.................. Filter, Prebypass, KRJ Cardiopulmonary Bypass. 870.4290.................. Adaptor, Stopcock, DTL Manifold, Fitting, Cardiopulmonary Bypass. 870.4340.................. Monitor and/or Control, DTW Level Sensing, Cardiopulmonary Bypass. 870.4420.................. Sucker, Cardiotomy DTS Return, Cardiopulmonary Bypass. 870.4430.................. Suction Control, DWD Intracardiac, Cardiopulmonary Bypass. 872.1720.................. Tester, Pulp............. EAT 872.3260.................. External Cleaning PME Solution. 872.3300.................. Coating, Denture EBE Hydrophilic, Resin. 872.3540.................. Pad, Denture, Over The EHR Counter. 872.3540.................. Cushion, Denture, Over EHS The Counter. 872.3560.................. Reliner, Denture, Over EBP The Counter. 872.3590.................. Denture, Plastic, Tooth.. ELM [[Page 31979]] 872.3600.................. Denture Preformed EKO (Partially Prefabricated Denture). 872.3890.................. Splint, Endodontic ELS Stabilizing. 872.5550.................. Ring, Teething, Fluid- KKO Filled. 872.6770.................. Syringe, Cartridge....... EJI 874.1120.................. Generator, Electronic ETS Noise (for Audiometric Testing). 874.1325.................. Electroglottograph....... KLX 874.3310.................. Calibrator, Hearing Aid/ ETW Earphone and Analysis Systems. 874.3320.................. Hearing Aid, Group and EPF Auditory Trainer. 874.3320.................. Device, Assistive LZI Listening. 874.3330.................. Hearing Aid, Master...... KHL 874.3430.................. Mold, Middle-Ear......... ETC 874.3730.................. Device, Voice MCK Amplification. 876.1500.................. Light Source, FCQ Incandescent, Diagnostic. 876.1500.................. Light Source, FCR Photographic, Fiberoptic. 876.1500.................. Light Source, Fiberoptic, FCW Routine. 876.1500.................. Carrier, Sponge, FGS Endoscopic. 876.1500.................. Light Source, Endoscope, GCT Xenon Arc. 876.1500.................. Transformer, Endoscope... GCW 876.1500.................. LED Light Source......... NTN 876.1500.................. Endoscopic Guide Wire, OCY Gastroenterology-Urology. 876.4020.................. Light, Catheter, FCS Fiberoptic, Glass, Ureteral. 876.4270.................. Rod, Colostomy........... EZP 876.4400.................. Ligator, Hemorrhoidal.... FHN 876.4400.................. Ligator, Esophageal...... MND 876.4500.................. Lithotriptor, Biliary LQC Mechanical. 876.4770.................. Urethrotome.............. EZO 876.5010.................. Bag, Bile Collecting..... EXF 876.5025.................. Vibrator for Climax PIA Control of Premature Ejaculation. 876.5365.................. Dilator, Esophageal EZM (Metal Olive) Gastro- Urology. 876.5365.................. Bougie, Esophageal, and FAT Gastrointestinal, Gastro- Urology. 876.5365.................. Dilator, Esophageal...... KNQ 876.5520.................. Dilator, Urethral........ KOE 876.5665.................. Disinfectant, Subsystem, NIH Water Purification. 876.5820.................. Set, Dialyzer Holder..... FKI 876.5895.................. Irrigator, Ostomy........ EXD 876.5980.................. Catheter, Retention, FGD Barium Enema With Bag. 876.5980.................. Gastrostomy Tube Holder.. PLI 878.4370.................. Drape, Surgical, ENT..... ERY 878.4370.................. Drape, Pure Latex Sheet, EYX With Self-Retaining Finger Cot. 878.4370.................. Drape, Urological, EYY Disposable. 878.4370.................. Pad, Kelly............... FNW 878.4370.................. Drape, Patient, HMT Ophthalmic. 878.4370.................. Drape, Microscope, HMW Ophthalmic. 878.4370.................. Ring (Wound Protector), KGW Drape Retention, Internal. 878.4580.................. Lamp, Operating-Room..... FQP 878.4580.................. Light, Surgical, FSQ Instrument. 878.4580.................. Light, Surgical, Floor FSS Standing. 878.4580.................. Light, Surgical, FSW Endoscopic. 878.4580.................. Light, Surgical, FSX Connector. 878.4580.................. Light, Surgical, Ceiling FSY Mounted. 878.4580.................. Light, Surgical, Carrier. FSZ 878.4580.................. Light, Surgical, FTA Accessories. 878.4580.................. Lamp, Surgical........... FTD 878.4580.................. Illuminator, Remote...... FTG 878.4580.................. Lamp, Surgical, GBC Incandescent. 878.5070.................. Apparatus, Air Handling, FZG Bench. 878.5070.................. Apparatus, Air Handling, FZH Room. 878.5070.................. Apparatus, Air Handling, FZI Enclosure. 880.5580.................. Locator, Acupuncture BWJ Point. 880.5580.................. Needle, Acupuncture, MQX Single Use. 880.5780.................. Stocking, Medical Support DWL (to Prevent Pooling of Blood in Legs). 882.1020.................. Analyzer, Rigidity....... GZM 882.1540.................. Device, Galvanic Skin GZO Response Measurement. 882.1560.................. Device, Skin Potential HCJ Measurement. 882.1855.................. Encephalogram Telemetry GYE System. 882.5895.................. Vibratory Counter- OVP Stimulation. 884.2990.................. Sheet, Recording, Breast NHM Examination. 884.3200.................. Drain, Cervical.......... HFL 884.4400.................. Forceps, Obstetrical..... HDA 884.4530.................. Clamp, Umbilical......... HFW 884.4530.................. Speculum, Vaginal, HIB Nonmetal. [[Page 31980]] 884.4530.................. Speculum, Vaginal, HIC Nonmetal, Fiberoptic. 884.4530.................. Clamp and Cutter, NBZ Umbilical. 884.4900.................. Table, Obstetrical, AC- HDD Powered (and Accessories). 884.4900.................. Table, Obstetrical, HHP Manual (and Accessories). 884.4900.................. Table, Obstetric (and KNC Accessories). 884.5200.................. Hemorrhoid Prevention OOA Pressure Wedge. 884.5390.................. Heater, Perineal, Direct HGZ Contact. 884.5390.................. Heater, Perineal, HHA Radiant, Non-Contact. 884.5390.................. Heater, Perineal......... KND 884.5400.................. Cup, Menstrual........... HHE 884.5425.................. Pad, Menstrual, Scented.. HHL 884.6150.................. Micromanipulators and MQJ Microinjectors, Assisted Reproduction. 886.1120.................. Photorefractor........... MMF 886.1120.................. Camera, Ophthalmic, PJZ General-Use. 886.1250.................. Euthyscope, AC-Powered... HMK 886.1570.................. Ophthalmoscope, AC- HLI Powered. 886.1570.................. Ophthalmoscope, Battery- HLJ Powered. 886.1570.................. Ophthalmoscopes, MSG Replacement Batteries, Hand-Held. 886.1780.................. Retinoscope, AC-Powered.. HKL 886.1945.................. Transilluminator, AC- HJM Powered. 886.4150.................. Tubing, Replacement, MSR Phacofragmentation Unit. 886.4250.................. Unit, Electrolysis, AC- HRO Powered, Ophthalmic. 886.4335.................. Headlight, Fiberoptic FCT Focusing. 886.4335.................. Light, Headband, Surgical FSR 886.4335.................. Headlamp, Operating, AC- HPQ Powered. 886.4400.................. Locator, Metal, HPM Electronic. 886.4440.................. Magnet, AC-Powered....... HPO 886.4790.................. Sponge, Ophthalmic....... HOZ 886.4790.................. Eye Tray................. OJK 888.1240.................. Dynamometer, AC-Powered.. LBB 888.4580.................. Instrument, Surgical, JDX Sonic and Accessory/ Attachment. 888.4580.................. System, Cement Removal LZV Extraction. 890.1450.................. Hammer, Reflex, Powered.. IKO 890.5100.................. Bath, Hydro-Massage...... ILJ 890.5100.................. Bath, Sitz, Powered...... ILM 890.5110.................. Bath, Paraffin........... IMC 890.5250.................. Cabinet, Moist Steam..... IMB 890.5360.................. Exerciser, Measuring..... ISD 890.5500.................. Lamp, Infrared, ILY Therapeutic Heating. 890.5575.................. Device, Warning, IRN Overload, External Limb, Powered. 892.1000.................. MRI Disposable Kit....... OIM 892.1560.................. Biopsy Needle Guide Kit.. OIJ 892.1610.................. Aperature, Radiographic.. IZS 892.1610.................. Cone, Radiographic....... IZT 892.1610.................. Collimator, Automatic, IZW Radiographic. 892.1610.................. Collimator, Manual, IZX Radiographic. 892.1610.................. Device, Beam Limiting, X- KPW Ray, Diagnostic. 892.1650.................. Arthrogram Tray.......... OII 892.1650.................. Radiology Dental Tray.... OIK 892.1670.................. Device, Spot-Film........ IXL 892.1680.................. Radiographic Contrast OIO Tray. 892.1680.................. Radiology Diagnostic Kit. OIP 892.1730.................. Discography Kit.......... OIL 892.1820.................. Chair, HBK Pneumocephalographic. 892.1850.................. Cassette, Radiographic IXA Film. 892.1860.................. Changer, Radiographic KPX Film/Cassette. 892.1870.................. Programmer, Changer, Film/ IZP Cassette, Radiographic. 892.1900.................. Controller, Temperature, EGT Radiographic. 892.1900.................. Dryer, Film, Radiographic EGW 892.1900.................. Processor, Radiographic- EGY Film, Automatic, Dental. 892.1900.................. Processor, Radiographic- IXW Film, Automatic. 892.1900.................. Processor, Cine Film..... IXX 892.2030.................. Digitizer, Image, LMA Radiological. 892.2030.................. Digitizer, Images, NFH Ophthalmic. 892.2040.................. Camera, Multi Format, LMC Radiological. 892.2040.................. Device, Hardcopy, Images, NFI Ophthalmic. 892.5730.................. Prostate Seeding Kit..... OIN ------------------------------------------------------------------------ [[Page 31981]] In table 2, FDA is identifying a list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in Sec. Sec. 862.9 to 892.9, as well as the indicated partial exemption limitations. Devices listed in table 2 are now exempt, but only if they are in concurrent compliance with both the partial exemption limitation specified in table 2 and its corresponding general limitation found in the .9 section of Parts 862 to 892 of Title 21 of the CFR. Table 2--Class II Devices ---------------------------------------------------------------------------------------------------------------- Exempt product Former product Partial exemption 21 CFR Section Device type code code (non-exempt) limitation ---------------------------------------------------------------------------------------------------------------- 862.3100....................... Enzyme PUX.............. DKZ.............. Exemption is limited Immunoassay, to test systems Amphetamine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100....................... Radioimmunoassay, PUX.............. DJP.............. Exemption is limited Amphetamine. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100....................... Thin Layer PUX.............. DIT.............. Exemption is limited Chromatography, to test systems Amphetamine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100....................... Gas PUX.............. DOD.............. Exemption is limited Chromatography, to test systems Amphetamine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100....................... Liquid PUX.............. DNI.............. Exemption is limited Chromatography, to test systems Amphetamine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100....................... Free Radical PUX.............. DJL.............. Exemption is limited Assay, to test systems Amphetamine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150....................... Enzyme PUY.............. DIS.............. Exemption is limited Immunoassay, to test systems Barbiturate. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31982]] 862.3150....................... Radioimmunoassay, PUY.............. DKN.............. Exemption is limited Barbiturate. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150....................... Thin Layer PUY.............. DKX.............. Exemption is limited Chromatography, to test systems Barbiturate. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150....................... Mercury PUY.............. DJN.............. Exemption is limited Dithiazone, to test systems Colorimetry, intended for Barbiturate. employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150....................... Hemagglutination PUY.............. DLX.............. Exemption is limited Inhibition, to test systems Barbiturate. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150....................... Gas Liquid PUY.............. DMF.............. Exemption is limited Chromatography, to test systems Barbiturate. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150....................... High Pressure PUY.............. KZY.............. Exemption is limited Liquid to test systems Chromatography, intended for Barbiturate. employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170....................... Enzyme PUZ.............. JXM.............. Exemption is limited Immunoassay, to test systems Benzodiazepine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170....................... High Pressure PUZ.............. LAA.............. Exemption is limited Liquid to test systems Chromatography, intended for Benzodiazepine. employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31983]] 862.3170....................... Test, PUZ.............. NFV.............. Exemption is limited Benzodiazepine, to test systems Over The Counter. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170....................... Gas PUZ.............. KZZ.............. Exemption is limited Chromatography, to test systems Benzodiazepine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170....................... Thin Layer PUZ.............. LAB.............. Exemption is limited Chromatography, to test systems Benzodiazepine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... Enzyme PVA.............. DIO.............. Exemption is limited Immunoassay, to test systems Cocaine and intended for Cocaine employment and Metabolites. insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... Radioimmunoassay, PVA.............. KLN.............. Exemption is limited Cocaine to test systems Metabolite. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... Enzyme PVA.............. JXO.............. Exemption is limited Immunoassay, to test systems Cocaine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... Hemagglutination, PVA.............. DLN.............. Exemption is limited Cocaine to test systems Metabolites intended for (Benzoylecgonine employment and ). insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... Thin Layer PVA.............. DMN.............. Exemption is limited Chromatography, to test systems Cocaine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31984]] 862.3250....................... Free Radical PVA.............. DIR.............. Exemption is limited Assay, Cocaine. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... Gas PVA.............. DIN.............. Exemption is limited Chromatography, to test systems Cocaine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... Thin Layer PVA.............. DOM.............. Exemption is limited Chromatography, to test systems Benzoylecgonine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250....................... High Pressure PVA.............. LAC.............. Exemption is limited Liquid to test systems Chromatography, intended for Cocaine and employment and Cocaine insurance testing Metabolites. that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3270....................... High Pressure PVB.............. LAE.............. Exemption is limited Liquid to test systems Chromatography, intended for Codeine. employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3270....................... Thin Layer PVB.............. DLD.............. Exemption is limited Chromatography, to test systems Codeine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3270....................... Gas PVB.............. LAD.............. Exemption is limited Chromatography, to test systems Codeine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3580....................... Radioimmunoassay, PVC.............. DLB.............. Exemption is limited LSD (125-I). to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31985]] 862.3580....................... Free Radical PVC.............. DOL.............. Exemption is limited Assay, LSD. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610....................... Gas PVD.............. LAF.............. Exemption is limited Chromatography, to test systems Methamphetamine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610....................... Thin Layer PVD.............. DJC.............. Exemption is limited Chromatography, to test systems Methamphetamine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610....................... High Pressure PVD.............. LAG.............. Exemption is limited Liquid to test systems Chromatography, intended for Methamphetamine. employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610....................... Test, PVD.............. NGG.............. Exemption is limited Methamphetamine, to test systems Over The Counter. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620....................... Enzyme PVE.............. DJR.............. Exemption is limited Immunoassay, to test systems Methadone. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620....................... Hemagglutination PVE.............. DIW.............. Exemption is limited Inhibition, to test systems Methadone. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620....................... Gas PVE.............. DMB.............. Exemption is limited Chromatography, to test systems Methadone. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31986]] 862.3620....................... Thin Layer PVE.............. DKR.............. Exemption is limited Chromatography, to test systems Methadone. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620....................... Liquid PVE.............. DNT.............. Exemption is limited Chromatography, to test systems Methadone. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620....................... Free Radical PVE.............. DPP.............. Exemption is limited Assay, Methadone. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3630....................... Radioimmunoassay, PVF.............. KXS.............. Exemption is limited Methaqualone. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Thin Layer PVG.............. DNK.............. Exemption is limited Chromatography, to test systems Morphine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Radioimmunoassay, PVG.............. DOE.............. Exemption is limited Morphine (123- to test systems I), Goat intended for Antibody employment and Ammonium Sulfate insurance testing Sep.. that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Fluorometry, PVG.............. DJJ.............. Exemption is limited Morphine. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Liquid PVG.............. DPK.............. Exemption is limited Chromatography, to test systems Morphine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31987]] 862.3640....................... Gas PVG.............. DMY.............. Exemption is limited Chromatography, to test systems Morphine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Hemagglutination PVG.............. DLR.............. Exemption is limited Inhibition, to test systems Morphine. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Free Radical PVG.............. DOK.............. Exemption is limited Assay, Morphine. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Radioimmunoassay, PVG.............. DIQ.............. Exemption is limited Morphine (3-H), to test systems Goat Antibody intended for Ammonium Sulfate employment and Sep.. insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640....................... Radioimmunoassay, PVG.............. DNA.............. Exemption is limited Morphine- to test systems Barbiturate (125- intended for I), Goat employment and Antibody. insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650....................... Enzyme PVH.............. DJG.............. Exemption is limited Immunoassay, to test systems Opiates. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650....................... Gas PVH.............. DJF.............. Exemption is limited Chromatography, to test systems Opiates. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650....................... Hemagglutination, PVH.............. DLT.............. Exemption is limited Opiates. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31988]] 862.3650....................... Thin Layer PVH.............. LAI.............. Exemption is limited Chromatography, to test systems Opiates. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650....................... Free Radical PVH.............. DKT.............. Exemption is limited Assay, Opiates. to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650....................... High Pressure PVH.............. LAH.............. Exemption is limited Liquid to test systems Chromatography, intended for Opiates. employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700....................... Enzyme PVI.............. JXN.............. Exemption is limited Immunoassay, to test systems Propoxyphene. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700....................... Thin Layer PVI.............. DPN.............. Exemption is limited Chromatography, to test systems Propoxyphene. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700....................... Gas PVI.............. LAJ.............. Exemption is limited Chromatography, to test systems Propoxyphene. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700....................... High Pressure PVI.............. LAK.............. Exemption is limited Liquid to test systems Chromatography, intended for Propoxyphene. employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3870....................... Enzyme PVJ.............. LDJ.............. Exemption is limited Immunoassay, to test systems Cannabinoids. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) [[Page 31989]] 862.3870....................... Reagents, Test, PVJ.............. DKE.............. Exemption is limited Tetrahydrocannab to test systems inol. intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3870....................... Radioimmunoassay, PVJ.............. LAT.............. Exemption is limited Cannabinoid(S). to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3910....................... High Pressure PVK.............. LFI.............. Exemption is limited Liquid to test systems Chromatography, intended for Tricyclic employment and Antidepressant insurance testing Drugs. that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3910....................... U.V. PVK.............. LFH.............. Exemption is limited Spectrometry, to test systems Tricyclic intended for Antidepressant employment and Drugs. insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3910....................... Thin Layer PVK.............. MLK.............. Exemption is limited Chromatography, to test systems Tricyclic intended for Antidepressant employment and Drugs. insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 866.5750....................... System, Test, PUW.............. DHB.............. Exemption is limited Radioallergosorb to devices classified ent (RAST) under 21 CFR 866.5750 Immunological. that are intended to detect any of the allergens included in table 3 of this document. 868.2385....................... Analyzer, PUG.............. MRQ.............. Exemption is limited Nitrogen Dioxide. to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy. 870.1330....................... Wire, Guide, PTL.............. DQX.............. Exemption is limited Catheter. to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non- cerebral vascular guide wires. 870.1650....................... Syringe, Balloon PTM.............. MAV.............. Exemption is limited Inflation. to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. 870.2770....................... Analyzer, Body PUH.............. MNW.............. Exemption is limited Composition. to body composition analyzers which are not intended to diagnose or treat any medical condition. 870.4400....................... Reservoir, Blood, PTN.............. DTN.............. Exemption is limited Cardiopulmonary to cardiopulmonary Bypass. bypass blood reservoirs that do not contain defoamers or blood filters. 874.1090....................... Tester, Auditory PTO.............. ETY.............. Exemption is limited Impedance. to auditory impedance testers that are in compliance with FDA- recognized consensus standard ANSI S3.39. 874.1090....................... Tympanometer..... PTP.............. NAS.............. Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39. 876.1500....................... Endoscopic PTQ.............. FCC.............. Exemption is limited Magnetic to endoscopic Retriever. magnetic retrievers intended for single use. 876.1500....................... Scissors For PTR.............. KGD.............. Exemption is limited Cystoscope. to sterile scissors for cystoscope intended for single use. [[Page 31990]] 876.1500....................... Endoscopic PTS.............. OCZ.............. Exemption is limited Grasping/Cutting to disposable, non- Instrument, Non- powered endoscopic Powered. grasping/cutting instruments intended for single use. 876.5010....................... Catheter, PTT.............. GCA.............. Exemption is limited Biliary, to surgical biliary Surgical. catheters that do not include a balloon component. 876.5630....................... Catheter, PTU.............. FJS.............. Exemption is limited Peritoneal, Long- to non-patient Term Indwelling. contacting catheter finger grips intended for single use. 876.5630....................... Catheter, PTV.............. FKO.............. Exemption is limited Peritoneal to non-patient Dialysis, Single contacting catheter Use. finger grips intended for single use. 876.5630....................... System, PTW.............. FKX.............. Exemption is limited Peritoneal, to continuous Automatic ambulatory peritoneal Delivery. dialysis (CAPD) belts and catheter stands that do not include weigh scales. 878.4370....................... Drape, Surgical.. PUI.............. KKX.............. Exemption is limited to surgical drapes that do not include an antimicrobial agent. 878.4495....................... Suture, PTX.............. GAQ.............. Exemption is limited Nonabsorbable, to steel monofilament Steel, sutures that are Monofilament And uncoated and do not Multifilament, incorporate barbs. Sterile. 882.1470....................... Computerized PTY.............. PKQ.............. Exemption is limited Cognitive to computerized Assessment Aid. cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand. 884.1630....................... Colposcope (and PTZ.............. HEX.............. Exemption is limited Colpomicroscope). to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based. 884.4530....................... Tenaculum, PUA.............. HDC.............. Exemption is limited Uterine. to sterile uterine tenaculum devices that do not use suction and are intended for single use. 884.6120....................... Accessory, PUB.............. MQG.............. Exemption is limited Assisted to simple embryo Reproduction. incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/ microscope stage warmers; and controlled-rate cryopreservation freezers. 884.6130....................... Microtools, PUC.............. MQH.............. Exemption is limited Assisted to assisted Reproduction reproduction (Pipettes). microtools (pipettes) manufactured from glass. 884.6160....................... Labware, Assisted PUD.............. MQK.............. Exemption is limited Reproduction. to dishes and plates that are intended for general assisted reproduction technology procedures. 886.1850....................... Biomicroscope, PUE.............. HJO.............. Exemption is limited Slit-Lamp, AC- to slit-lamp, AC- Powered. powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications. 886.3320....................... Ocular Peg....... PUF.............. MQU.............. Exemption is limited to ocular pegs supplied sterile. ---------------------------------------------------------------------------------------------------------------- In table 2, FDA included devices classified under Sec. 866.5750 (Radioallergosorbent (RAST) immunological test system). FDA does not believe that all devices classified under this regulation meet the exemption criteria from premarket notification requirements. The devices listed in table 3 are also classified under Sec. 866.5750, but this subset no longer requires premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in Sec. 866.9. While the non-exempt devices classified under Sec. 866.5750 will retain product code ``DHB'', these devices listed in table 3 are reassigned product code ``PUW.'' Table 3--Class II Devices [Sec. 866.5750--Radioallergosorbent (RAST) Immunological Test Systems] ------------------------------------------------------------------------ Source (taxonomical Allergen code Allergen product name) ------------------------------------------------------------------------ Grass Pollens ------------------------------------------------------------------------ g1.................... Sweet vernal grass..... Anthoxanthum odoratum. g3.................... Cocksfoot grass, Dactylis glomerata. Orchard grass. g4.................... Meadow fescue.......... Festuca elatior. g5.................... Rye-grass (perennial Lolium perenne. rye grass). g7.................... Common reed (common Phragmites communis. reed grass). g8.................... Meadow grass, Kentucky Poa pratensis. blue (June grass). [[Page 31991]] g9.................... Redtop, Bentgrass...... Agrostis stolonifera Agrostis gigantea (Agrostis alba). g11................... Brome grass............ Bromus inermis. g12................... Cultivated rye Secale cereale. (cultivated rye grass). g13................... Velvet grass........... Holcus lanatus. g14................... Cultivated oat Avena sativa. (cultivated oat grass). g15................... Cultivated wheat Triticum aestivum (cultivated wheat (Triticum spp.). grass). g16................... Meadow foxtail (meadow Alopecurus pratensis. foxtail grass). g17................... Bahia grass............ Paspalum notatum. g24................... Wheat grass, Western... Agropyron smithii (Elymus smithii). g30................... Bluegrass, annual...... Poa annua. g70................... Wild rye grass......... Elymus triticoides Elymus condensatus. g71................... Canary grass........... Phalaris arundinacea. g201.................. Barley, cultivated..... Hordeum vulgare. g202.................. Maize, corn (cultivated Zea mays. corn). g203.................. Salt grass............. Distichlis spicata. g204.................. False oat-grass........ Arrhenatherum elatius. g216.................. Cyn d 1................ Cynodon dactylon. g701.................. Phl p 1.0102, Phl p Phleum pratense. 5.0101. g702.................. Phl p 7.0101........... Phleum pratense. g703.................. Phl p 12.0101.......... Phleum pratense. ------------------------------------------------------------------------ Weed Pollens ------------------------------------------------------------------------ w2.................... Western ragweed........ Ambrosia psilostachya. w4.................... False ragweed.......... Ambrosia acanthicarpa (Franseria acanthicarpa). w5.................... Wormwood............... Artemisia absinthium Artemisia annua. w6.................... Mugwort................ Artemisia vulgaris. w7.................... Marguerite, ox-eye Chrysanthemum daisy. leucanthemum. w8.................... Dandelion.............. Taraxacum vulgare Taraxacum officinale. w9.................... Plantain (English), Plantago lanceolata. Ribwort. w10................... Goosefoot, lamb's Chenopodium album. quarters. w11................... Saltwort (prickly), Salsola kali Russian thistle. (Salsola pestifer). w12................... Goldenrod.............. Solidago virgaurea (Solidago spp.) w13................... Cocklebur, common...... Xanthium commune. w14................... Common pigweed (rough Amaranthus retroflexus. pigweed). w15................... Scale, Lenscale........ Atriplex lentiformis. w16................... Rough marsh elder...... Iva ciliate Iva annua. w17................... Firebush (Kochia)...... Kochia scoparia. w18................... Sheep sorrel........... Rumex acetosella. w19................... Wall pellitory......... Parietaria officinalis. w20................... Nettle (Common stinging Urtica dioica. nettle). w21................... Wall pellitory......... Parietaria judaica. w22................... Japanese hop (careless Humulus japonicas weed). (Humulus scandens). w23................... Yellow dock, Yellow Rumex crispus. dockweed. w24................... Spiny pigweed.......... Amaranthus spinosus. w27................... Carnation.............. Dianthus spp. w28................... Rose................... Rosa rugosa. w33................... Clover................. Trifolium pratense. w35................... Mexican tea............ Chenopodium ambrosioides. w36................... Rabbit bush............ Ambrosia deltoidea (Franseria deltoides). w37................... Salt bush, annual...... Atriplex wrightii. w39................... Water hemp, Western.... Amaranthus rudis (Acnida tamariscina). w41................... Burrobrush............. Hymenoclea salsola. w42................... Poverty weed........... w43................... Common sagebrush....... Artemisia tridentata. w45................... Alfalfa................ Medicago sativa. w46................... Dog fennel............. Eupatorium capillifolium. [[Page 31992]] w53................... Geranium............... Geranium spp. w67................... Groundsel bush......... Baccharis halimifolia. w69................... Iodine bush............ Allenrolfea occidentalis. w70................... Ragweed, slender....... Ambrosia confertiflora. w75................... Wing scale (wingscale). Atriplex canescens. w82................... Careless weed.......... Amaranthus palmeri Amaranthus hybridus. w90................... Japanese hop........... Humulus japonicas (Humulus scandens). w203.................. Rape (rape pollen)..... Brassica napus. w204.................. Sunflower.............. Helianthus annuus. w206.................. Camomile............... Matricaria chamomilla. w207.................. Lupin.................. Lupinus spp. w210.................. Sugar-beet............. Beta vulgaris. w211.................. Par j 2.0101........... Parietaria judaica. w231.................. Art v 1................ Artemisia vulgaris (Mugwort). w232.................. Sal k 1................ Salsola kali. w233.................. Art v 3................ Artemisa vulgaris (LTP, Mugwort). w234.................. Pla l 1................ Plantago lanceolata. w235.................. Che a 1.0101........... Chenopodium album. w236.................. Mer a 1.0101........... Mercurialis annua. a753.................. Art v 1................ Artemisia vulgaris (Mugwort weed). ------------------------------------------------------------------------ Tree Pollens ------------------------------------------------------------------------ t1.................... Box-elder (Maple)...... Acer negundo. Acer saccharum. t2.................... Gray alder, speckled Alnus incana. alder (alder). t4.................... Hazel, hazelnut........ Corylus avellana. Corylus americana. t5.................... American beech (beech). Fagus grandifolia. (Fagus americana). t6.................... Mountain juniper, Juniperus ashei Mountain cedar. (Juniperus sabinoides). t8.................... Elm.................... Ulmus americana. t9.................... Olive.................. Olea europaea. t10................... Walnut................. Juglans californica Juglans nigra. t11................... Maple leaf sycamore, Platanus acerifolia. London plane, Plane tree. t61................... Sycamore............... Platanus occidentalis. t12................... Willow................. Salix caprea Salix nigra. t14................... Cottonwood (Eastern Populus deltoides. Cottonwood/Black Cottonwood). t15................... White ash.............. Fraxinus americana. t16................... White pine............. Pinus strobus. t18................... Eucalyptus, gum-tree... Eucalyptus globulus. (Eucalyptus spp.). t19/t26............... Acacia................. Acacia longifolia (Acacia spp.). t20................... Mesquite............... Prosopis glandulosa/ Prosopis juliflora. t21................... Melaleuca, cajeput tree Melaleuca quinquenervia (Melaleuca leucadendron). t22................... Pecan, hickory......... Carya illinoinensis (Carya pecan). t23................... Italian/Mediterranean/ Cupressus sempervirens. funeral cypress. t24................... Japanese cypress....... Chamaecyparis obtusa (Chamaecyparis spp.). t25................... Ash.................... Fraxinus excelsior. t27................... Maple, red............. Acer rubrum. t29................... Acacia................. Acacia spp. t30................... Birch, white........... Betula populifolia. t32................... Willow, black.......... Salix nigra. t33................... Ash, Arizona........... Fraxinus velutina. t35................... Cedar, salt............ Tamarix gallica. t37................... Bald cypress (white Taxodium distichum. bald cypress). t38................... Elm, Chinese/Siberian.. Ulmus pumila. t40................... Hazelnut tree.......... Corylus americana. t41................... White hickory.......... Carya alba (Carya tomentosa). t42................... Oak, red............... Quercus rubra. t43................... Loblolly pine.......... Pinus taeda. t44................... Hackberry.............. Celtis occidentalis. [[Page 31993]] t45................... Cedar elm.............. Ulmus crassifolia. t47................... Juniper, one seed...... Juniperus monosperma. t48................... Pine, lodgepole........ Pinus contorta. t49................... Pine, ponderosa........ Pinus ponderosa. t50................... Beech, European........ Fagus sylvatica. t51................... Tree of Heaven......... Ailanthus altissima. t52................... Western white pine..... Pinus monticola. t54................... Russian olive.......... Elaeagnus angustifolia. t55................... Scotch broom........... Cytisus scoparius. t56................... Bayberry............... Myrica cerifera. t57................... Red cedar.............. Juniperus virginiana. t60................... Western juniper........ Juniperus occidentalis. t61................... Sycamore............... Platanus occidentalis. t70................... Mulberry (white Morus alba. mulberry). t71................... Red mulberry........... Morus rubra. t72................... Queen palm............. Arecastrum romanzoffiamon. t73................... Australian pine........ Casuarina equisetifolia. t77................... Oak mix (red, white, Quercus spp. black). t80................... Japanese cypress....... Chamaecyparis obtusa. t81................... Japanese alder......... Alnus japonica. t83................... Mango tree............. Mangifera indica. t90................... Walnut, black.......... Juglans nigra. t96................... Poplar, white (poplar). Populus alba. t103/................. Virginia live oak (live Quercus virginiana. t218.................. oak). t105.................. Pepper tree............ Schinus molle. t110.................. Orange tree............ Citrus sinensis. t201.................. Spruce, Norway spruce.. Picea abies (Picea excelsa). t202.................. Alder, smooth.......... Alnus incana spp. Rugosa (Alnus rugosa). t203.................. Horse chestnut......... Aesculus hippocastanum. t205.................. Elder.................. Sambucus nigra. t206.................. Chestnut............... Castanea sativa. t207.................. Douglas fir............ Pseudotsuga menziesii (Pseudotsuga taxifolia). t208.................. Linden................. Tilia cordata. t209.................. Horn beam.............. Carpinus betulus. t210.................. Privet................. Ligustrum vulgare. t211.................. Sweet gum.............. Liquidambar styraciflua. t212.................. Cedar.................. Libocedrus decurrens. t213.................. Pine................... Pinus radiata. t214.................. Date palm.............. Phoenix canariensis. t215.................. Lilac.................. Syringa vulgaris. t217.................. Pepper tree............ Schinus molle. t217.................. Red alder.............. Alnus rubra. t218.................. Virginia live oak...... Quercus virginiana. t218.................. Bayberry (bayberry/ Myrica gale. sweet gale). t219.................. Palo verde............. Cercidium floridum. t219.................. Red cedar.............. Juniperus virginiana. t220.................. Bet v 4................ Betula verrucosa (Birch). t221.................. Bet v 2.0101, Bet v 4.. Betula verrucosa (Birch). t222.................. Cypress (Arizona Cupressus arizonica. cypress). t223.................. Oil palm............... Elaeis guineensis. t224.................. Ole e 1................ Olea europaea. t225.................. Bet v 6................ Betula verrucosa (Birch). t226.................. Cup a 1................ Cupressus arizonica. t227.................. Ole e 7................ Olea Europaea. t228.................. Aspen, quaking......... Populus tremuloides. t229.................. Eastern hemlock........ Tsuga canadensis. t230.................. Redwood (sequoia)...... Sequoia sempervirens. t232.................. Pussy willow........... Salix discolor. t240.................. Ole e 9.0101........... Olea Europaea. t241.................. Pla a 1.0101........... Platanus acerifolia. t242.................. Pla a 2................ Platanus acerifolia. t243.................. Pla a 3.0101........... Platanus acerifolia. t244.................. Cor a 1.0103........... Corylus avellana. t245.................. Aln g 1.0101........... Alnus glutinosa. t246.................. Cry j 1................ Cryptomeria japonica. t280.................. Locust tree............ Robinia pseudoacacia. t401.................. Brazilian peppertree... Schinus terebinthifolius. t402.................. Mastic tree............ Pistacia lentiscus. [[Page 31994]] t404.................. Tree of heaven......... Ailanthus altissima. t406.................. Date palm.............. Phoenix dactylifera. a482.................. Ole e 1................ Olea europaea (Olive Oil). ------------------------------------------------------------------------ Mites ------------------------------------------------------------------------ d207.................. Blo t 5.0101........... Blomia tropicalis. d208.................. Lep d 2.0101........... Lepidoglyphus destructor. ------------------------------------------------------------------------ Microorganisms, Molds, Yeast ------------------------------------------------------------------------ m1.................... Penicillium chrysogenum Penicillium chrysogenum (Penicillium notatum).. (Penicillium notatum). m2.................... Cladosporium herbarum Cladosporium herbarum (Hormodendrum). (Hormodendrum). m3.................... Aspergillus fumigatus.. Aspergillus fumigatus. m4.................... Mucor racemosus........ Mucor racemosus. m5.................... Candida albicans....... Candida albicans. m7.................... Botrytis cinerea....... Botrytis cinerea. m8.................... Drechslera halodes Drechslera halodes (Setomelanomma (Setomelanomma rostrata, rostrata, Helminthosporium Helminthosporium halodes, halodes). Helminthosporium interseminatum). m9.................... Fusarium moniliforme Fusarium moniliforme (Fusarium (Fusarium proliferatum). proliferatum). m10................... Stemphylium botryosum.. Stemphylium herbarum (Stemphylium botryosum). m11................... Rhizopus nigricans..... Rhizopus nigricans. m12................... Aureobasidium pullulans Aureobasidium pullulans. m13................... Phoma betae............ Phoma betae. m14................... Epicoccum purpurascens. Epicoccum purpurascens (Epicoccum nigrum). m15................... Trichoderma viride..... Trichoderma viride. m16................... Curvularia lunata...... Curvularia lunata Curvularia specifera (K923044). m17................... Cladosporium fulvum.... Cladosporium fulvum. m18................... Fusarium culmorum...... Fusarium culmorum. m19................... Aspergillus versicolor. Aspergillus versicolor. m20................... Mucor mucedo........... Mucor mucedo. m21................... Aspergillus clavatus... Aspergillus clavatus. m22................... Micropolyspora faeni... Saccharopolyspora rectivirgula (Micropolyspora faeni). m23................... Thermoactinomyces Thermoactinomyces vulgaris. vulgaris. m24................... Stachybotrys atra...... Stachybotrys chartarum (Stachybotrys atra). m24................... Paecilomyces spp....... Paecilomyces spp. m25................... Aspergillus versicolor. Aspergillus versicolor. m25................... Penicillium Penicillium brevicompactum. brevicompactum. m26................... Cladosporium Cladosporium cladosporioides. cladosporioides. m26................... Penicillium citrinum... Penicillium citrinum. m27................... Penicillium spp........ Penicillium spp. m29................... Aspergillus repens..... Aspergillus repens. m30................... Penicillium roqueforti. Penicillium roqueforti. m32................... Cladosporium Cladosporium cladosporioides. cladosporioides. m34................... Serpula lacrymans...... Serpula lacrymans. m36................... Aspergillus terreus.... Aspergillus terreus. m37................... Trichophyton Trichophyton mentagrophytes. mentagrophytes. m40................... Aspergillus amstelodami Aspergillus amstelodami. m43................... Saccharomyces carlsberg Saccharomyces carlsbergensis. m44................... Saccharomyces Saccharomyces cerevisiae. cerevisiae. m45................... Hormodendrum hordei.... Hormodendrum hordei. m46................... Bipolaris spicifera.... Bipolaris spicifera. m47................... Aspergillus nidulans... Aspergillus nidulans. m48................... Aspergillus oryzae..... Aspergillus oryzae. m49................... Fusarium oxysporum..... Fusarium oxysporum. m50................... Micropolyspora faeni... Saccharopolyspora rectivirgula (Micropolyspora faeni). m51................... Thermoactinomyces Thermoactinomyces vulgaris. vulgaris. m53................... Microspora canis....... Microsporum canis (Microspora canis). m54................... Aspergillus flavus..... Aspergillus flavus. m63................... Helminthosporium Helminthosporium intersemin. intersemin. m66................... Mucor plumbeus......... Mucor plumbeus. m67................... Mycogone............... Mycogone perniciosa. m68................... Nigrospora oryzae...... Nigrospora oryzae. [[Page 31995]] m69................... Rhodotorula............ Rhodotorula rubra (Rhodotorula mucilaginosa). m70................... Malassezia furfur Malassezia furfur (Pityrosporum (Pityrosporum orbiculare). orbiculare). m71................... Spondylocladium........ Spondylocladium spp. m72................... Epidermophyton......... Epidermophyton floccosum. m73................... Epicoccum nigrum....... Epicoccum purpurascens (Epicoccum nigrum). m80................... Staphylococcal Staphylococcus aureus. enterotoxin A (Sta a SEA). m80................... Helminthosporium spp... Helminthosporium spp. m81................... Staphylococcal Staphylococcus aureus. enterotoxin B (Sta a SEB). m88................... Stemphylium solani..... Stemphylium solani. m93................... Gliocladium fimbriatum. Gliocladium fimbriatum. m94................... Phycomyces Phycomyces blakesleeanus. blakesleeanus. m201.................. Tilletia tritici Tilletia tritici (Ustilago nuda, (Ustilago nuda, Ustilago tritici) Ustilago tritici). (Barley smut). m202.................. Acremonium kiliense Acremonium kiliense (Cephalosporium (Cephalosporium acremonium). acremonium). m203.................. Trichosporon pullulans. Trichosporon pullulans. m204.................. Ulocladium chartarum... Ulocladium chartarum. m205.................. Trichophyton rubrum.... Trichophyton rubrum. m207.................. Aspergillus niger...... Aspergillus niger. m208.................. Chaetomium globosum.... Chaetomium globosum. m209.................. Penicillium frequentans Penicillium glabrum (Penicillium frequentans). m209.................. Stachybotrys chartarum. Stachybotrys chartarum (Stachybotrys atra). m210.................. Trichophyton Trichophyton mentagrophytes var. mentagrophytes var. goetzii. goetzii. m211.................. Trichophyton Trichophyton mentagrophytes var. mentagrophytes var. interdigitale. interdigitale. m211.................. Oat smut............... Ustilago avenae. m212.................. Micropolyspora faeni... Saccharopolyspora rectivirgula (Micropolyspora faeni). m212.................. Geotrichum candidum.... Geotrichum candidum. m213.................. Bermuda grass smut..... Ustilago cynodontis. m214.................. Johnson grass smut..... Sphacelotheca cruenta. m215.................. Corn smut.............. Ustilago maydis. m218.................. Asp f 1.0101........... Aspergillus fumigatus. a3050................. Asp r 1................ Aspergillus restrictus. m219.................. Asp f 2................ Aspergillus fumigatus. m220.................. Asp f 3.0101........... Aspergillus fumigatus. m221.................. Asp f 4................ Aspergillus fumigatus. m222.................. Asp f 6.0101........... Aspergillus fumigatus. m223.................. Staphylococal Staphylococus aureus. enterotoxin C (Sta a SEC). m224.................. Staphylococcal Staphylococcus aureus. enterotoxin D (Sta a SED). m226.................. Staphylococcal Staphylococcus aureus. enterotoxin TSST (Sta a TSST). m227.................. Malassezia spp. Malassezia spp. (Pityrosporum spp.). (Pityrosporum spp.). m228.................. Aspergillus flavus..... m229.................. Alt a 1.0101........... Alternaria alternata (Alternaria tenuis). m230.................. Alt a 6.0101........... Alternaria alternata (Alternaria tenuis). m231.................. Cla h 8.0101........... Cladosporium herbarum (Hormodendrum). m300.................. Eurotium spp........... Eurotium spp. m304.................. Aspergillus oryzae..... Aspergillus oryzae. m305.................. Penicillium Penicillium brevicompactum. brevicompactum. m309.................. Aspergillus terreus.... Aspergillus terreus. m310.................. Aspergillus nidulans... Aspergillus nidulans. m311.................. Aspergillus flavus..... Aspergillus flavus. m312.................. Aspergillus clavatus... Aspergillus clavatus. ------------------------------------------------------------------------ Epidermal & Animal ------------------------------------------------------------------------ e6.................... Guinea pig epithelium.. Cavia porcellus. e7.................... Pigeon droppings....... Columba palumbus Columba livia. e25................... Chicken serum.......... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26................... Parrot serum........... Psittacoidea spp. e62................... Camel.................. Camelus dromedaries. e70................... Goose feathers......... Anser anser. e71................... Mouse epithelium....... Mus musculus (Mus spp.). e73................... Rat epithelium......... Rattus norvegicus. e74................... Rat urine proteins..... Rattus norvegicus Rattus rattus. [[Page 31996]] e75................... Rat serum proteins..... Rattus norvegicus Rattus rattus. e76................... Mouse serum proteins... Mus musculus (Mus spp.). e77................... Budgerigar droppings... Melopsittacus undulatus. e78................... Budgerigar feathers.... Melopsittacus undulatus. e79................... Budgerigar serum Melopsittacus proteins. undulatus. e80................... Goat epithelium........ Capra hircus. e81................... Sheep epithelium....... Ovis aries (Ovis spp.). e82................... Rabbit epithelium...... Oryctolagus cuniculus (Oryctolagus spp.). e83................... Swine epithelium....... Sus scrofa (Sus scrofa domesticus; Sus spp.). e84................... Hamster epithelium..... Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus. e85................... Chicken feathers....... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86................... Duck feathers.......... Anas platyrhynchos. e87................... Rat epithelium, serum Rattus norvegicus proteins, and urine Rattus rattus. proteins. e88................... Mouse epithelium, serum Mus musculus (Mus proteins, and urine spp.). proteins (mouse). e89................... Turkey feathers........ Meleagris gallopavo. e90................... Budgerigar serum Melopsittacus proteins, feathers, undulatus. and droppings. e91................... Pigeon serum proteins, Streptopelia feathers, and roseogrisea droppings. Psittacidae spp. e92................... Parrot serum proteins, Ara spp. feathers, and droppings. e93................... Pigeon serum proteins.. Streptopelia roseogrisea. e94................... Fel d 1.0101........... Felis domesticus. a345.................. Fel d 1................ Felis domesticus. e98................... Parrot droppings....... Psittacoidea spp. e101.................. Can f 1.0101........... Canis familiaris (Canis domesticus). a174.................. Can f 1................ Canis familiaris (Canis domesticus). e102.................. Can f 2.0101........... Canis familiaris (Canis domesticus). e196.................. Parakeet feathers...... Nymphicus hollandicus. e197.................. Parakeet droppings..... Nymphicus hollandicus. e198.................. Parakeet serum......... Nymphicus hollandicus. e199.................. Canary bird serum...... Serinus canarius. e200.................. Canary bird droppings.. Serinus canarius. e201.................. Canary bird feathers Serinus canarius. (Canary feathers). e202.................. Reindeer epithelium.... Rangifer tarandus. e203.................. Mink epithelium........ Mustela spp. e204.................. Bos d 6................ Bos domesticus (Bos taurus; Bos spp.). e205.................. Horse, serum proteins.. Equus caballus (Equus spp.). e206.................. Rabbit, serum proteins. Oryctolagus cuniculus (Oryctolagus spp.). e208.................. Chinchilla epithelium.. Chinchilla laniger. e209.................. Gerbil epithelium...... Meriones unguiculatus. e210.................. Fox epithelium......... Vulpes vulpes. e211.................. Rabbit, urine proteins. Oryctolagus cuniculus (Oryctolagus spp.). e212.................. Swine, urine proteins.. Sus scrofa (Sus scrofa domesticus; Sus spp.). e213.................. Parrot feathers........ Ara spp. e214.................. Finch feathers......... Lonchura domestica. e215.................. Pigeon feathers........ Streptopelia roseogrisea (Streptopelia spp.) Columbia spp. e216.................. Deer epithelium........ Dama dama. e217.................. Ferret epithelium...... Mustela putorius. e218.................. Chicken droppings...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219.................. Chicken, serum proteins Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e220.................. Fel d 2, Cat serum Felis domesticus. albumin. e221.................. Can f 3................ Canis familiaris (Canis domesticus) (Dog serum albumin). e222.................. Swine serum albumin Sus scrofa (Sus scrofa (Sus s PSA). domesticus; Sus spp.). e225.................. Lovebird feathers...... Psittacoidea agapomis. e226.................. Can f 5.0101........... Canis familiaris. e227.................. Equ c 1.0101........... Equus caballus. e228.................. Fel d 4.0101........... Felis domesticus. e230.................. Equ c 3................ Equus caballus. [[Page 31997]] e231.................. Mus m 1................ Mus musculus. ------------------------------------------------------------------------ Food ------------------------------------------------------------------------ f9.................... Rice................... Oryza sativa. f12................... Pea (green pea)........ Pisum sativum. f15................... White bean............. Phaseolus vulgaris. f19................... Cayenne pepper......... Capsicum frutescens (Capsicum annum). f21................... Sugar cane............. Saccharum officinarum. f22................... Raspberry.............. Rubus idaeus. f26................... Pork................... Sus scrofa (Sus scrofa domesticus; Sus spp.). f29................... Watermelon............. Citrullus lanatus (Citrullus vulgaris). f31................... Carrot................. Daucus carota. f32................... Oyster mushroom........ Pleurotus ostreatus. f33................... Orange................. Citrus sinensis. f35................... Potato................. Solanum tuberosum. f43................... Mother's milk.......... Homo sapiens. f44................... Strawberry............. Fragaria vesca (Fragaria spp.). f45................... Yeast, baker's......... Saccharomyces cerevisiae. f46................... Pepper, Red............ Capsicum annuum. f47................... Garlic................. Allium sativum. f48................... Onion.................. Allium cepa. f49................... Apple.................. Malus x domestica (Malus spp.). f51................... Bamboo shoot........... Phyllostachys pubescens. f52................... Cacao/chocolate........ Theobroma cacao. f54................... Sweet potato........... Ipomoea batatas. f55................... Common millet.......... Panicum miliaceum. f56................... Foxtail millet......... Setaria italica. f57................... Japanese millet........ Echinochloa crus-galli. f58................... Pacific squid.......... Todarodes pacificus. f59................... Octopus................ Octopus vulgaris (Octopus spp.). f63................... Kefir.................. NA. f67................... Parmesan cheese........ NA. f81................... Cheese, cheddar type... NA. f82................... Cheese, mold type...... NA. f83................... Chicken................ Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86................... Parsley................ Petroselinum crispum. f87................... Melon.................. Cucumis melo Cucumis melo + Citrullus lanatus. f88................... Mutton (lamb).......... Ovis aries (Ovis spp.). f90................... Malt................... Hordeum vulgare. f92................... Banana................. Musa spp. f93................... Cacao.................. Theobroma cacao. f94................... Pear................... Pyrus communis (Pyrus spp.). f97................... Yam.................... Dioscorea spp. Dioscorea opposita. f97................... Chamomile tea.......... Matricaria chamomilla. f98................... Gliadin................ Triticum aestivum (Triticum spp.). f102.................. Cantaloupe............. Cucumis melo var. cantalupensis. f105.................. Chocolate.............. Theobroma cacao. f109.................. Cottonseed............. Gossypium hirsutum. f110.................. Giant radish........... Raphanus sativus. f118.................. Zucchini............... Cucurbita pepo. f119.................. Radish................. Raphanus sativus. f120.................. Venison................ Capreolus capeolus. f121.................. Pinto bean............. Phaseolus vulgaris. f122.................. Cheese, American....... NA. f127.................. Black-eyed pea......... Vigna unguiculata. f131.................. Black Olive............ Olea europaea. f136.................. Red beet............... Beta vulgaris var. conditiva. f139.................. Goat's Cheese.......... Capra aegagrus. f140.................. Bran................... NA. f141.................. Corn (vegetables)...... Zea mays. f152.................. Green bell pepper...... Capsicum annuum. f155.................. Brewer's yeast......... Saccharomyces carlsbergensis. f157.................. Duck................... Anas domesticus. f158.................. Goose.................. Anser anser. f160.................. Camembert cheese....... NA. [[Page 31998]] f162.................. Nectarine.............. Prunus persica var. nucipersica. f163.................. Kohlrabi............... Brassica oleracea var. gongylodes. f65................... Perch.................. f166.................. Leek................... Allium porrum. f170.................. Cheese (Switzerland) NA. (Swiss cheese). f174.................. Fig.................... Ficus carica. f177.................. Cranberry.............. Vaccinium macrocarpon. f179.................. Raisin................. Vitis spp. f182.................. Lima bean.............. Phaseolus lunatus. f198.................. Flaxseed (bruised Linum usitatissimum. grain). f199.................. Untreated native milk.. Bos domesticus (Bos taurus; Bos spp.). f208.................. Lemon.................. Citrus limon. f209.................. Grapefruit............. Citrus paradisi. f210.................. Pineapple.............. Ananas comosus. f211.................. Blackberry............. Rubus fruticosus. f212.................. Mushroom (champignon).. Agaricus hortensis (Agaricus spp.). f213.................. Rabbit................. Oryctolagus cuniculus (Oryctolagus spp.). f214.................. Spinach................ Spinacia oleracea. f215.................. Lettuce................ Lactuca sativa. f216.................. Cabbage................ Brassica oleracea var. capitata. f217.................. Brussels sprouts....... Brassica oleracea var. gem. f218.................. Paprika, sweet pepper.. Capsicum annuum. f219.................. Fennel seed............ Foeniculum vulgare. f219.................. Sage................... Salvia officinalis. f220.................. Cinnamon............... Cinnamomum spp. f221.................. Coffee................. Coffea spp. f222.................. Tea.................... Camellia sinensis. f223.................. Green olive............ Olea europaea. f225.................. Summer squash, pumpkin. Cucurbita pepo. f225.................. Pumpkin................ Cucurbita maxima. f226.................. Pumpkin seed........... Cucurbita pepo. f227.................. Sugar-beet seed........ Beta vulgaris. f229.................. Safflower Seed......... Carthamus tinctorius. f231.................. Milk, boiled........... Bos domesticus (Bos taurus; Bos spp.). f234.................. Vanilla................ Vanilla planifolia. f237.................. Apricot................ Prunus armeniaca. f241.................. Gouda cheese........... NA. f242.................. Cherry................. Prunus avium. f244.................. Cucumber............... Cucumis sativus. f246.................. Guar, guar gum......... Cyamopsis tetragonoloba. f247.................. Honey.................. NA. f248.................. Rosemary............... Rosmarinus officinalis. f254.................. Plaice................. Pleuronectes platessa. f255.................. Plum................... Prunus domestica Prunus americana. f258.................. Squid.................. Loligo spp. f259.................. Grape.................. Vitis vinifera (Vitis spp.). f260.................. Broccoli............... Brassica oleracea var. italica (Brassica oleracea var. cultivar). f261.................. Asparagus.............. Asparagus officinalis. f262.................. Aubergine, eggplant.... Solanum melongena. f263.................. Green pepper........... Piper nigrum Capsicum annuum. f264.................. Eel.................... Anguilla anguilla. f265.................. Caraway................ Carum carvi. f265.................. Cumin.................. Cuminum cyminum. f266.................. Mace................... Myristica fragrans. f267.................. Cardamon............... Elettaria cardamomum. f268.................. Clove.................. Syzygium aromaticum. f269.................. Basil.................. Ocimum basilicum. f270.................. Ginger................. Zingiber officinale. f271.................. Anise.................. Pimpinella anisum. f272.................. Tarragon............... Artemisia dracunculus. f273.................. Thyme.................. Thymus vulgaris. f274.................. Marjoram............... Origanum majorana. f275.................. Lovage................. Levisticum officinale. f276.................. Fennel, fresh.......... Foeniculum vulgare. [[Page 31999]] f277.................. Dill................... Anethum graveolens. f278.................. Bay leaf............... Laurus nobilis. f279.................. Chili pepper........... Capsicum frutescens. f280.................. Black pepper........... Piper nigrum. f281.................. Curry (Santa Maria).... NA. f282.................. Nutmeg................. Myristica fragrans. f283.................. Oregano................ Origanum vulgare. f284.................. Turkey meat............ Meleagris gallopavo. f285.................. Elk/moose meat......... Alces spp. f286.................. Mare's milk............ Equus caballus (Equus spp.). f287.................. Red kidney bean........ Phaseolus vulgaris. f288.................. Blueberry.............. Vaccinium myrtillus (Vaccinium spp.). f289.................. Date................... Phoenix dactylifera. f291.................. Cauliflower............ Brassica oleracea var. botrytis. f292.................. Guava.................. Psidium guajava. f293.................. Papaya................. Carica papaya. f294.................. Passion fruit, Maracuja Passiflora edulis (Passiflora spp.). f295.................. Carambola.............. Averrhoa carambola. f296.................. Carob.................. Ceratonia siliqua. f297.................. Gum arabic............. Acacia senegal (Acacia spp.). f298.................. Tragacanth............. Astragalus spp. f299.................. Sweet chestnut Castanea sativa. (chestnut). f300.................. Pinto bean............. Phaseolus spp. f301.................. Persimmon (kaki fruit, Diospyros kaki. sharon). f302.................. Mandarin (tangerine, Citrus reticulata. clementine, satsumas). f305.................. Fenugreek.............. Trigonella foenum- graecum. f306.................. Lime................... Citrus aurantifolia. f307.................. Hake................... Merluccius merluccius. f308.................. Sardine (pilchard)..... Sardina pilchardus. f310.................. Blue vetch............. Lathyrus sativus. f311.................. Megrim................. Lepidorhombus whiffiagonis. f315.................. Green bean............. Phaseolus vulgaris. f316.................. Rape seed.............. Brassica napus. f317.................. Coriander.............. Coriandrum sativum. f318.................. Jack fruit............. Artocarpus heterophyllus. f319.................. Beetroot............... Beta vulgaris. f320.................. Crayfish............... Astacus astacus. f321.................. Horse meat............. Equus caballus (Equus spp.). f322.................. Red currant............ Ribes sylvestre. f324.................. Hop (fruit cone)....... Humulus lupulus. f325.................. Saffron................ Colchicum autumnale. f328.................. Fig.................... Ficus carica. f329.................. Watermelon............. Citrullus lanatus. f330.................. Rose hip............... Rosa spp. f331.................. Saffron................ Crocus sativus. f332.................. Mint................... Mentha piperita. f333.................. Linseed................ Linum usitatissimum. f336.................. Jujube................. Ziziphus jujuba. f336.................. Wine vinegar........... Vitis vinifera (Vitis spp.). f337.................. Sole................... Solea solea. f337.................. English sole........... Parophrys vetulus. f338.................. Wine, white............ Vitis vinifera (Vitis spp.). f339.................. Allspice............... Pimenta dioica. f339.................. Wine, red.............. Vitis vinifera (Vitis spp.). f341.................. Cranberry.............. Vaccinium oxycoccus Vaccinium macrocarpon. f342.................. Olive (black, fresh)... Olea europaea. f343.................. Raspberry.............. Rubus idaeus. f344.................. Sage................... Salvia officinalis. f346.................. Chives................. Allium schoenoprasum. f347.................. Quinoa................. Chenopodium quinoa. f348.................. Litchi................. Litchi chinensis. f349.................. Chum salmon roe........ Oncorhynchus keta. f358.................. Artichoke.............. Cynara scolymus. f360.................. Yogurt................. NA. f368.................. Black bass............. Micropterus dolomieu (Micropterus dolomieui). f374.................. Karaya gum............. Sterculia urens. f375.................. Horseradish............ Armoracia rusticana. f377.................. Maple syrup............ NA. f379.................. Okra................... Abelmoschus esculentus. [[Page 32000]] f382.................. Beet, sugar............ Beta vulgaris var. altissima. f401.................. Loquat................. Eriobotrya japonica. f402.................. Fig.................... Ficus carica. f403.................. Brewer's yeast......... Saccharomyces cerevisiae. f405.................. Mint................... Mentha spp. f406.................. Arugula................ Eruca vesicaria. ------------------------------------------------------------------------ House Dust ------------------------------------------------------------------------ h1.................... Greer Labs., Inc....... NA. h2.................... Hollister-Stier Labs... NA. h6.................... Japan.................. NA. ------------------------------------------------------------------------ Venoms & Insects ------------------------------------------------------------------------ i7.................... Midge.................. Chironomus yoshimatsui. i8.................... Moth................... Bombyx mori Heterocera spp. i47................... Water flea............. Daphnia spp. i49................... Deer fly............... Chrysops spp. i51................... Black ant.............. Camponotus pennsylvanicus. i54................... Flea mix (dog/cat), Ctenocephalides spp. common flea. i71................... Mosquito............... Aedes communis Aedes spp. and Culex spp. i72................... Green nimitti.......... Cladotanytarsus lewisi. i73................... Blood worm............. Chironomus thummi Chironomusri parius Chironomus spp. i75................... European hornet........ Vespa crabro. i76................... Berlin beetle.......... Trogoderma angustum. i77................... European paper wasp.... Polistes dominulus. i78................... Fly.................... Musca domestica. i80................... Bumblebee.............. Bombus pennsylvanicus. i201.................. Horse bot fly.......... Gasterophilus intestinalis. i202.................. Grain weevil........... Sitophilus granarius. i203.................. Mediterranean flour Ephestia kuehniella moth. (Anagasta kuehniella). i204.................. Horse fly.............. Tabanus spp. i205.................. Bumblebee.............. Bombus terrestris. i208.................. Api m 1.0101........... Apis mellifera. a45................... Api m 1................ Apis mellifera. i209.................. Ves v 5.0101........... Vespula vulgaris. a670.................. Ves v 5................ Vespula vulgaris. i210.................. Pol d 5.0101........... Polistes dominulus. i211.................. Ves v 1.0101........... Vespula vulgaris. i213.................. Api m 4................ Apis mellifera. i214.................. Api m 2................ Apis mellifera. i215.................. Api m 3................ Apis mellifera. i216.................. Api m 5................ Apis mellifera. i217.................. Api m 10............... Apis mellifera. i220.................. Bla g 1.0101........... Blattella germanica. i221.................. Bla g 2.0101........... Blattella germanica. i222.................. Bla g 5.0101........... Blattella germanica. i223.................. Bla g 7................ Blattella germanica a46................... Api m 2................ Apis mellifera. ------------------------------------------------------------------------ Miscellaneous ------------------------------------------------------------------------ o1.................... Cotton, crude fibers... Gossypium spp. o3.................... Cotton (treated)....... Gossypium spp. o70................... Seminal fluid.......... Homo sapiens. o71................... Staphylococcus aureus.. Staphylococcus aureus. o72................... Pichia pastoris crude Pichia pastoris. extract customer specific. o72................... Sperm-sediment......... Homo sapiens. o73................... Pichia pastoris crude Pichia pastoris. extr. vector customer specific. o74................... Pichia pastoris with Pichia pastoris. vector customer specific. o201.................. Tobacco leaf, tobacco Nicotiana tabacum. dust. o202.................. Artemia salina, fish Artemia salina. feed. o203.................. Tetramin, fish feed.... NA. o207.................. Daphnia, fish feed..... Daphnia spp. o211.................. Mealworm............... Tenebrio molitor. [[Page 32001]] o212.................. Streptavidin........... Streptomyces avidini. o213.................. MBP (maltose binding Escherichia coli. protein). o214.................. CCD; MUXF3 from Ananas comosus. bromelain. o72................... Enterotoxin A (Sta a Staphylococcus aureus. SEA). o73................... Enterotoxin B (Sta a Staphylococcus aureus. SEB). ------------------------------------------------------------------------ Parasites ------------------------------------------------------------------------ p1.................... Ascaris................ Ascaris suum. p2.................... Echinococcus........... Echinococcus granulosus. p3.................... Schistosoma............ Schistosoma mansoni. p4.................... Anisakis (Herring Worm) Anisakis simplex (Anisakis spp.). p5.................... Toxocara canis......... Toxocara canis. p10................... Ani s 3.0101........... Anisakis simplex (Anisakis spp.). p11................... Ani s 1................ Anisakis simplex (Anisakis spp.). ------------------------------------------------------------------------ Occupational ------------------------------------------------------------------------ k4.................... Threshing dust......... NA. k5.................... Flax................... NA. k7.................... Hay Dust............... NA. k8.................... Hop (hops)............. Humulus lupulus. k12................... Grain mill dust........ NA. k14................... Kapok.................. NA. k20................... Sheep's wool (treated) Ovis aries (Ovis spp.). (wool). k21................... Sheep's wool Ovis aries (Ovis spp.). (Untreated). k23................... Straw Dust............. NA. k33................... Oak.................... NA. k70................... Green coffee bean...... Coffea spp. k71................... Castor bean............ Ricinus communis. k72................... Ispaghula.............. Plantago psyllium/ Plantago ovata. k73................... Silk waste............. NA. k74................... Silk................... Bombyx mori. k75................... Isocyanate TDI (Toluene NA. diisocyanate). k76................... Isocyanate MDI NA. (Diphenylmethane diisocyanate). k77................... Isocyanate HDI NA. (Hexamethylen diisocyanate). k78................... Ethylene oxide......... NA. k79................... Phthalic anhydride..... NA. k80................... Formaldehyde/Formalin.. NA. k81................... Ficus.................. Ficus benjamina (Ficus spp.). k83................... Cotton seed............ Gossypium hirsutum. k84................... Sunflower seed......... Helianthus annuus. k85................... Chloramin T............ NA. k86................... Trimellitic anhydride, NA. TMA. k87................... Asp o 21, alpha-amylase Aspergillus oryzae. k89................... Orris root............. Iris florentina. k99................... HSA (Human Serum Homo sapiens. Albumin) (Hom s HSA). k201.................. Car p 1, Papain........ Carica papaya. k202.................. Ana c 2, Bromelain..... Ananas comosus. k204.................. Maxatase............... Bacillus licheniformis. k205.................. Alcalase............... Bacillus spp. k206.................. Savinase, Protease 1 Bacillus spp. (Bac l Subtilisin). k208.................. Gal d 4, Lysozyme...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209.................. Hexahydrophtalic NA. anhydrid. k210.................. Maleic anhydride....... NA. k211.................. Methyltetrahydrophtalic NA. anhydrid. k212.................. Abachi wood dust....... Triplochiton scleroxylon. k213.................. Pepsin (Sus s Pepsin).. Sus scrofa (Sus scrofa domesticus; Sus spp.). k213.................. TCPA................... NA. k214.................. Bougainvillea.......... Bougainvillea spp. k225.................. Horse radish peroxidase Armoracia rusticana. (Arm r HRP). k226.................. Ascorbate oxidase (Cuc Cucurbita pepo. p ascorbate oxidase). k301.................. Flour dust............. Triticum spp. k501.................. Savinase customer Proprietary knowledge specific. of customer. k502.................. Lipolase customer Proprietary knowledge specific. of customer. k503.................. Termamyl customer Proprietary knowledge specific. of customer. k504.................. Clazinase customer Proprietary knowledge specific. of customer. ------------------------------------------------------------------------ [[Page 32002]] V. Reference The following reference is on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA Guidance, ``Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff,'' February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Dated: July 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-14453 Filed 7-10-17; 8:45 am] BILLING CODE 4164-01-P
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration | |
Section | Notices | |
Action | Notice. | |
Contact | Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: [email protected] | |
FR Citation | 82 FR 31976 |