FDA clearance for BioMérieux products, 9/15
BioMérieux announced the FDA 510(k) clearance and commercial availability of Vidas 3, the new generation of Vidas. Vidas 3 features enhanced automation, in particular the preanalytical section from the barcoded primary tube including dilution, improved traceability, and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Vidas 3 is CE marked and registered at the Chinese Food and Drug Administration.