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August 16, 2022

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 15, 2022. To view listings for other dates, see CDRH New - News and Updates.

• Reissued Emergency Use Authorizations
  • Gravity Diagnostics COVID-19 Test Home Collection Kit (Gravity Diagnostics, LLC)
  • Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics, LLC)
  • GENETWORx Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
  • GenBody COVID-19 Ag (GenBody Inc.)
• Revised Emergency Use Authorizations
  • cobas SARS-COV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems, Inc.)
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
  • Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
  • INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
  • INDICAID COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International, Ltd.)