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Remel, Inc.
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PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY is an FDA 510(k)-cleared medical device (K033479) manufactured by Remel, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 25, 2004. Regulation: 8.