VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL

VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL is an FDA 510(k)-cleared medical device (K172944) 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 December 18, 2017. Regulation: 8.