AXSYM CMV IGG ANTIBODY ASSAY

AXSYM CMV IGG ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K953943) 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 September 19, 1996. Regulation: 8.