BioMérieux Receives FDA Clearance for Vitek MS Clinical Microbiology System | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration said yesterday that it has granted BioMérieux's Vitek MS clinical microbiology mass spectrometry system 510(k) de novo clearance.

The system, which uses MALDI-TOF mass spec to identify disease-causing organisms including bacteria and yeast, is the first such platform cleared for clinical use in the US. The Vitek MS identifies microbes by matching the protein profiles of sample organisms generated via MALDI mass spec to profiles contained in a proprietary database.

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