CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

October 6, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 5, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel (UMass Memorial Medical Center)
  • BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
  • OmniPATH COVID-19 Total Antibody ELISA Test (Thermo Fisher Scientific)
  • Sofia 2 Flu + SARS Antigen FIA (Quidel Corporation)
• Re-issued Emergency Use Authorizations
  • Cuur Diagnostics SARS-CoV-2 Molecular Assay (Cuur Diagnostics)
  • MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit (Detectachem Inc.)
• Updated Emergency Use Authorizations
  • Smart Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc)
• FAQs on Testing for SARS-CoV-2 (Updated)
• NOTICE OF MEETING POSTPONEMENT: October 7, 2020 Circulatory System Devices Panel of the Medical Devices Advisory Committee
• Medical Device Reporting (MDR): How to Report Medical Device Problems (Updated)