VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG) is an FDA 510(k)-cleared medical device (K902925) manufactured by Vitek Systems, 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 8, 1990. Regulation: 8.