VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)

VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) is an FDA 510(k)-cleared medical device (K222378) 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 25, 2023. Regulation: 8.