CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY

CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K904329) 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 March 11, 1991. Regulation: 8.