VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)

VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) is an FDA 510(k)-cleared medical device (K163563) 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 March 12, 2017. Regulation: 8.