Sofia Influenza A+B FIA on Sofia 2

Sofia Influenza A+B FIA on Sofia 2 is an FDA 510(k)-cleared medical device (K162438) manufactured by Quidel Corporation. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 2017. Regulation: 8.