BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY

BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K924006) manufactured by Baxter Healthcare Corp. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 28, 1992. Regulation: 8.