FDA Clears BD's C. Difficile Test as IVD

Jan 14, 2009

NEW YORK (GenomeWeb News) — Becton Dickinson unit BD Diagnostics said yesterday that it has received 510(k) clearance from the US Food and Drug Administration to sell its molecular diagnostic test to identify the bacterium Clostridium difficile in the US.

The company's GeneOhm Cdiff test is a rapid stool test to identify the bug's Toxin B gene, which is found in toxigenic C. difficile bacteria.

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