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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
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