The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the LightMix[supreg] Zika rRT-PCR Test. FDA revoked this Authorization on March 13, 2017, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. by letter dated March 10, 2017. 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 Zika Virus
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the ...
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82 FR 29883
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“Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus,” thefederalregister.org (June 30, 2017), https://thefederalregister.org/documents/2017-13666/revocation-of-authorization-of-emergency-use-of-an-in-vitro-diagnostic-device-for-detection-of-zika-virus.