VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) is an FDA 510(k)-cleared medical device (K232967) 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 11, 2024. Regulation: 8.