BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is an FDA 510(k)-cleared medical device (K160161) 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 February 23, 2016. Regulation: 8.