VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)

VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) is an FDA 510(k)-cleared medical device (K181368) 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 June 19, 2018. Regulation: 8.