Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUAs) (the Authorizations) issued to Southern California Permanente Medical Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
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