VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)

VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) is an FDA 510(k)-cleared medical device (K161437) 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 February 15, 2017. Regulation: 8.