Meridian Bioscience Submits C. Difficile MDx Test to FDA | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Meridian Bioscience has submitted a 510(k) application with the US Food and Drug Administration for its illumigene C. difficile molecular diagnostic test.

The illumigene C. difficile test detects and amplifies a pathogenic DNA region of all toxin-producing strains of Clostridium difficile. The test uses a stool sample and can provide results in less than an hour, said Meridian.

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