VITEK 2 GRAM NEGATIVE TIGECYCLINE

VITEK 2 GRAM NEGATIVE TIGECYCLINE is an FDA 510(k)-cleared medical device (K052311) 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 28, 2005. Regulation: 8.