VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)

VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) is an FDA 510(k)-cleared medical device (K193567) 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 13, 2020. Regulation: 8.