VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) is an FDA 510(k)-cleared medical device (K260281) manufactured by BIOMERIEUX. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2026. Regulation: 8.