VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) is an FDA 510(k)-cleared medical device (K210287) manufactured by bioMerieux, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2021. Regulation: 8.