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Bd Diagnostics (Geneohm Sciences, Inc.)
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BD GENEOHM CDIFF ASSAY is an FDA 510(k)-cleared medical device (K081920) manufactured by Bd Diagnostics (Geneohm Sciences, Inc.). This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 18, 2008. Regulation: 8.