ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A is an FDA 510(k)-cleared medical device (K871233) 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.