CDRH New - June 2, 2022

June 2, 2022

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 1, 2022. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • AdvanSure SARS-CoV-2 IgG(RBD) ELISA (LG Chem, Ltd.)
• Reissued Emergency Use Authorizations
  • SARS-CoV-2 IgG (Abbott Laboratories Inc.)
• Reissued and Revised Emergency Use Authorizations
  • BioFire Covid-19 Test (Biofire Defense, LLC)
• Revised Emergency Use Authorizations
  • UCSD EXCITE COVID-19 EL Test (UCSD BCG EXCITE Lab)
  • SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.)
  • SCoV-2 Ag Detect Rapid Test ((InBios International Inc.)
• Updated Emergency Use Authorizations 
  • MiraDx SARS-CoV-2 RT-PCR assay (MiraDx)
  • QIAreach SARS-CoV-2 Antigen (QIAGEN GmbH)
• MQSA National Statistics (Updated)