BioFire COVID-19 Test 2

BioFire COVID-19 Test 2 is an FDA 510(k)-cleared medical device (K221460) manufactured by Biofire Defense, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 24, 2022. Regulation: 8.