FDA Clears Roche Cobas C. Diff Test | GenomeWeb

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance to a Clostridium difficile test from Roche, the firm announced today.

The test detects the C. diff toxin B gene from stool samples. It runs on Roche's cobas 4800 system, which combines automated sample preparation with real-time PCR amplification and detection for mixed batch testing.

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