Revocation of Two 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 Bio-Rad Laboratories, Inc., for the Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit and to Applied DNA Sciences, Inc., for the Linea COVID-19 Assay Kit. 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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