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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