Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/ IgM Rapid Test, BioM[eacute]rieux SA for the SARS-COV-2 R-GENE, Siemens Healthcare Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G), Siemens Healthcare Diagnostics Inc. for the ADVIA Centaur SARS-CoV-2 IgG (COV2G), and Cepheid for the Xpert Omni SARS-CoV-2. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
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