Accula Flu A/Flu B Test

Accula Flu A/Flu B Test is an FDA 510(k)-cleared medical device (K171641) manufactured by Mesa Biotech, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2018. Regulation: 8.