VIDAS CMV IGM ASSAY

VIDAS CMV IGM ASSAY is an FDA 510(k)-cleared medical device (K933549) manufactured by Biomerieux Vitek, 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 1, 1994. Regulation: 8.