The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Zalgen Labs, LLC for the ReEBOV Antigen Rapid Test. FDA revoked this Authorization on May 18, 2018, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Zalgen Labs, LLC by letter dated March 1, 2018. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
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Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Virus
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Zalgen Labs, LLC for the ReEBOV Antige...
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83 FR 37813
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“Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Virus,” thefederalregister.org (August 2, 2018), https://thefederalregister.org/documents/2018-16537/revocation-of-authorization-of-emergency-use-of-an-in-vitro-diagnostic-device-for-detection-of-ebola-virus.