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June 20, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 16, 2023. To view listings for other dates, see CDRH New - News and Updates.

• Reissued Emergency Use Authorizations
  • Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
  • Lucira by Pfizer COVID-19 & Flu Test (Lucira Health, Inc.)
  • Lucira by Pfizer COVID-19 & Flu Home Test (Lucira Health, Inc.)
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems, Inc.)
• Updated Emergency Use Authorization
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
• Revoked Emergency Use Authorization
  • BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Company (BD))