On Nov. 1, 2021, the U.S. Food and Drug Administration (FDA) cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2 from BioFire Defense.

The test, which had been offered under an Emergency Use Authorization (EUA) since March 2020, was the second SARS-CoV-2 diagnostic test granted marketing authorization that permits the test to be marketed beyond the public health emergency.