BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN

BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN is an FDA 510(k)-cleared medical device (K913229) 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 August 28, 1991. Regulation: 8.