BD Veritor™ System Flu A+B Assay

BD Veritor™ System Flu A+B Assay is an FDA 510(k)-cleared medical device (K133138) 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 November 12, 2013. Regulation: 8.