INFLUENZA A & B S-ANTIGEN & CONTROLS

INFLUENZA A & B S-ANTIGEN & CONTROLS is an FDA 510(k)-cleared medical device (K802931) manufactured by Orion Diagnostica, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 11, 1981. Regulation: 8.