CDRH New - June 30, 2021

June 30, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 29, 2021. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • CareStart EZ COVID-19 IgM/IgG (Access Bio, Inc.)
• Reissued Emergency Use Authorizations
  • CareStart COVID-19 IgM/IgG (Access Bio, Inc.)
• Revised Emergency Use Authorizations
  • ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
  • COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc.)
  • GeneFinder COVID-19 Plus RealAmp Kit (OSANG Healthcare)
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
• Updated Emergency Use Authorizations
  • qSanger-COVID-19 Assay (BillionToOne, Inc.)
  • TRUPCR SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.)
  • ViroKey SARS-CoV-2 RT-PCR Test (Vela Operations Singapore Pte Ltd)
  • PhoenixDx SARS-CoV-2 Multiplex (Trax Management Services Inc.)
  • Clinomics TrioDx RT-PCR COVID-19 Test (Clinomics USA Inc.)
  • Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics)
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
• Waiver and Acknowledgment posted for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
• Federal Register: Medical Devices-Exemption From Premarket Notification; Powered Patient Transport, All Other Powered Patient Transport: Correction
• Federal Register: MedWatch; The Food and Drug Administration Medical Products Reporting Program