BD Announces FDA 510(k) Clearance of Molecular Assay

BD Diagnostics, a segment of BD announced it has received clearance from the U.S. Food and Drug Administration to market the BD GeneOhm Cdiff molecular assay for the rapid detection of the Toxin B gene found in toxigenic Clostridium difficile, the bacterial pathogen responsible for Clostridium difficile infection (CDI).
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