VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY is an FDA 510(k)-cleared medical device (K905211) manufactured by Vitek Systems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 10, 1991. Regulation: 8.