BD DIRECTIGEN EZ FLU A+B ASSAY

BD DIRECTIGEN EZ FLU A+B ASSAY is an FDA 510(k)-cleared medical device (K101529) 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 June 13, 2010. Regulation: 8.