VITEK 2 AST-Gram Positive Cefoxitin Screen

VITEK 2 AST-Gram Positive Cefoxitin Screen is an FDA 510(k)-cleared medical device (K220805) 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 12, 2022. Regulation: 8.