BD DIRECTIGEN EZ FLU A + B

BD DIRECTIGEN EZ FLU A + B is an FDA 510(k)-cleared medical device (K042472) manufactured by Becton, Dickinson & CO. 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 6, 2005. Regulation: 8.