BioMérieux Gets FDA’s 510(k) Clearance for its Mass Spectrometry System

In vitro diagnostics company bioMérieux’s Vitek MS Prime mass spectrometry identification system has received 510(k) clearance from the FDA.

The compact benchtop system is integrated with the company’s fully automated Vitek 2 system for bacterial identification and antibiotic susceptibility testing. 

The Vitek MS Prime system allows for prioritization of urgent samples and continuous “load and go” operation, the company said.