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BioMérieux gets FDA 510(k) clearance for Vitek MS Prime

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March 18, 2022—BioMérieux announced the Vitek MS Prime, its new MALDI-TOF mass spectrometry identification system, received FDA 510(k) clearance. The compact benchtop system analyzes material from microbial cultures to provide microorganism identification in minutes.

“With Vitek MS Prime, we provide our U.S. customers with an innovative system that brings greater lab workflow efficiency. Extensive lab input was incorporated into the development of Vitek MS Prime, so we know the unique and differentiating features like prioritization of urgent samples and continuous ‘load and go’ will be valued,” Brian Armstrong, senior vice president of clinical operations, North America, said in a press statement.

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