INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION

INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION is an FDA 510(k)-cleared medical device (K884191) manufactured by Baxter Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 21, 1988. Regulation: 8.