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March 7, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 6, 2023. To view listings for other dates, see CDRH New - News and Updates.

• Revised Emergency Use Authorizations
  • Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
  • Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
  • Sofia SARS Antigen FIA (Quidel Corporation)
  • VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.)
  • Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)
• Reissued Emergency Use Authorizations
  • Umbrella EUA for Surgical Masks
• Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)
• Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee