CDRH New

December 17, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 16, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • GENETWORx Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
  • PacificDx Covid-19 Test (ResearchDx, Inc., DBA Pacific Diagnostics)
  • ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
  • BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
• Re-issued Emergency Authorizations
  • Phosphorus COVID-19 RT-qPCR Test (Phosphorus Diagnostics LLC)
• Updated Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
• News Release: Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)