FDA authorizations for EUAs

by t_king

FDAAs of June 10, 2022, The FDA has authorized 437 tests and sample collection devices under emergency use authorizations (EUAs). These include:

  • 302 molecular tests and sample collection devices
  • 85 antibody and other immune response tests
  • 49 antigen tests
  • 1 diagnostic breath test
  • 80 molecular authorizations
  • 1 antibody authorization that can be used with home-collected samples
  • 1 EUA for a molecular prescription at-home test
  • 2 EUAs for antigen prescription at-home tests
  • 17 EUAs for antigen over-the-counter (OTC) at-home tests
  • 3 for molecular OTC at-home tests.

The FDA has also authorized 27 antigen tests and 8 molecular tests for serial screening programs as well as authorizing 1000 revisions to EUA authorizations.

Please click on this FDA link to read this announcement on COVID-19 as well as many more announcements and updates!

Compliance Insight