Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
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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 cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted at the end of this document.
Abstract as published in the Federal Register.
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