CDRH New - November 12, 2021

November 12, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on November 10, 2021. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Revogene SARS-CoV-2 (Meridian Bioscience, Inc.)
• Reissued Emergency Use Authorizations
  • QuickVue SARS Antigen Test (Quidel Corporation)
• Revised Emergency Use Authorizations
  • Orawell IgM/IgG Rapid Test (Jiangsu Well Biotech Co., Ltd)
• Updated Emergency Use Authorizations
  • Talis One COVID-19 Test System (Talis Biomedical Corporation)
  • Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo Fisher Scientific Inc.)
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc)
• Consumer Information on: ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters – P200004
• Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
• Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety (Updated)
• Activities to Support Medical Device Innovators (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200033 added)