IMX CMV IGM ANTIBODY ASSAY

IMX CMV IGM ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K900473) manufactured by Abbott Laboratories. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 1990. Regulation: 8.