VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)

VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) is an FDA 510(k)-cleared medical device (K202396) 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 September 13, 2021. Regulation: 8.