CDRH New - August 31, 2022

If your email program has trouble displaying this email, view as a webpage. August 31, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 30, 2022. To view listings for other dates, see CDRH New - News and Updates. Revised Emergency Use Authorizations Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc. ) CareStart COVID-19 Antigen Home Test (Access Bio, Inc.) Genabio COVID-19 Rapid Self-Test Kit (Genabio Diagnostics Inc.) NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.) BioCode CoV-2 Flu Plus Assay (Applied BioCode, Inc.) MicroGEM Sal6830 SARS-CoV-2 Saliva Test (MicroGEM U.S., Inc.) Revoked Emergency Use Authorizations Talis One COVID-19 Test System (Talis Biomedical Corporation) Updated Emergency Use Authorizations SARS-CoV-2 Assay (Nationwide Children's Hospital) Transcript for: July 12-13, 2022 Patient Engagement Advisory Committee Meeting  Transcript for: July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

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