PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY

PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY is an FDA 510(k)-cleared medical device (K964864) manufactured by Alexon Biomedical, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 3, 1997. Regulation: 8.