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- FDA Revokes Emergency Use Authorizations for Six COVID-19 Tests
On March 21, the Food and Drug Administration (FDA) revoked six Emergency Use Authorizations (EUAs) of in vitro diagnostic devices for detection and/or diagnosis of COVID-19 to:
- Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit
- Bio-Rad Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay Kit
- Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit
- bioMérieux SA, for the VIDAS SARS-CoV-2 IgM kit
- bioMérieux SA, for the VIDAS SARS-CoV-2 IgG kit
- Luminex Corp., for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay
When an EUA is revoked or terminated, there will be a date beyond which the test(s) can no longer be used. Make sure to discontinue use and discard any remaining product inventory whose EUA was revoked. These items will no longer be available and if a lab uses them, they will need to find a replacement.
For additional FDA guidance visit: Emergency Use Authorization of Medical Products and Related Authorities.