CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 28, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 25, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Xpert Xpress SARS-CoV-2 (Cepheid)
  • COVIAGE (Duke University)
  • COViage (Dascena, Inc.)
• Re-issued Emergency Use Authorization
  • Panther Fusion SARS-CoV-2 Assay (Hologic, Inc.)
• Updated Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test (Roche Molecular Systems, Inc.)
  • AvellinoCoV2 test (Avellino Lab USA, Inc.)
  • Acupath COVID-19 Real-Time (RT-PCR) Assay (Acupath Laboratories, Inc.)
  • BD SARS-CoV-2Reagents for BD MAX System (Becton, Dickinson & Company)
  • Assure COVID-19 IgG/IgM Rapid Test Device (Assure Tech. (Hangzhou Co., Ltd))
• Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication
• FAQs on Testing for SARS-CoV-2 (Update)