SOFIA ANALYZER AND INFLUENZA A+B FIA

SOFIA ANALYZER AND INFLUENZA A+B FIA is an FDA 510(k)-cleared medical device (K112177) manufactured by Quidel Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2011. Regulation: 8.