CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 24, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 23, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Clarifi COVID-19 Test Kit (Quadrant Biosciences Inc.)
  • ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte. Ltd.)
• Updated Emergency Use Authorizations
  • ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (ScienCell Research Laboratories)
  • BioGX SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company (BD))
  • SARS-CoV-2 PCR Test (Centers for Disease Control and Prevention (CDC))
  • Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Genomics, Inc.)
  • LabGun COVID-19 RT-PCR Kit (LabGenomics Co., Ltd.)
  • Assure COVID-19 IgG/IgM Rapid Test Device (Assure Tech. - Hangzhou Co., Ltd)
• Revoked Emergency Use Authorizations
  • Umbrella of Infusion Pumps and Infusion Pump Accessories
• FAQs on Testing for SARS-CoV-2 (Update)