bioMérieux has created a new Fungal Susceptibility Card for susceptibility testing of Candida species and Cryptococcus neoformans. The VITEK 2 ASTYS07 card includes a sixth antifungal agent, ...
This presentation will give an update about easing the administrative burden on the lab to assess compliance with CLSI/FDA breakpoints. Topics addressed included FDA 510(k) approvals, the VITEK® V9.04 ...
MARCY L'ÉTOILE, France, March 18, 2025 /PRNewswire/ --bioMérieux, a world leader in the field of in vitro diagnostics, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance for VITEK® ...
The 510(k) clearances were granted to a dozen in vitro diagnostic tests and reagents which used a variety of detection methods and approaches.
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