ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B is an FDA 510(k)-cleared medical device (K871231) manufactured by Microscan Div. Baxter Healthcare Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 25, 1987. Regulation: 8.