VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) is an FDA 510(k)-cleared medical device (K152075) 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 April 14, 2016. Regulation: 8.