BIOSIGN FLU A + B, STATUS FLU A & B

BIOSIGN FLU A + B, STATUS FLU A & B is an FDA 510(k)-cleared medical device (K132465) manufactured by Princeton BioMeditech 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 September 8, 2013. Regulation: 8.