CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

October 1, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 30, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Aeon Global Health SARS-CoV-2 Assay (Aeon Global Health)
  • CentoSure SARS-CoV-2 RT-PCR Assay (CENTOGENE US, LLC)
  • Akron Children’s Hospital SARS-CoV-2 Assay (Akron Children’s Hospital)
  • SARS-CoV-2 MassArray Test (National Jewish Health)
  • DiaSorin LIAISON SARS-CoV-2 IgM Assay (DiaSorin, Inc.)
  • FREND COVID-19 total Ab (NanoEntek America, Inc.)
  • Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit (Nirmidas Biotech, Inc.)
• LIAISON XL MUREX HBsAg Confirmatory test, LIAISON® XL MUREX Control HBsAg, LIAISON® XL MUREX Qual HBsAg - P190017
• SARS-CoV-2 Reference Panel Comparative Data (Updated)
• Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers
• Presentation and Transcript added to Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests Webinar - September 23, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)