VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) is an FDA 510(k)-cleared medical device (K212243) 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 August 7, 2022. Regulation: 8.