Revocation of Eleven 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 Authorizations (EUAs) (the Authorizations) issued to Luminostics, Inc., for the Clip COVID Rapid Antigen Test; NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay; LGC, Biosearch Technologies for the SARS-CoV-2 Real-Time and End-Point RT-PCR Test; LGC, Biosearch Technologies, for the Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test; Becton, Dickinson and Co. for the BD Veritor At-Home COVID-19 Test; Verily Life Sciences for the Verily COVID-19 RT-PCR Test; Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3); Xtrava Health for the SPERA COVID-19 Ag Test; Exact Sciences Laboratories for the COVID-Flu Multiplex Assay; Exact Sciences Laboratories for the SARS-CoV-2 (N gene detection) Test; and dba SpectronRx for the Hymon SARS-CoV-2 Test Kit. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

Abstract as published in the Federal Register.

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