CDRH New - January 11, 2022

January 11, 2022

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 10, 2022. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorization
  • PMLS SARS-CoV-2 Assay (Premier Medical Laboratory Services)
• Reissued Emergency Use Authorizations
  • GWU SARS-CoV-2 RT-PCR Test (George Washington University Public Health Laboratory)
  • COVID-19 At-Home Test (SD Biosensor, Inc.)
• Updated Emergency Use Authorizations
  • AQ-TOP COVID-19 Rapid Detection Kit (Seasun Biomaterials, Inc.)
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
  • FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) (PreciGenome LLC)
  • PowerChek 2019-nCoV Real-time PCR Kit (KogeneBiotech Co., Ltd.)
  • PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
  • BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
  • BinaxNOW COVID-19 Ag Card 2 Home Test (Abbott Diagnostics Scarborough, Inc.)
  • BinaxNOW COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)
• Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act - Draft Guidance for Industry and Staff
• Class I Recall: Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210015 added)
• Federal Register: Permanent Discontinuance or Interruption in Manufacturing of a Device under the Federal Food, Drug, and Cosmetic Act