ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY

ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K954318) 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 May 13, 1996. Regulation: 8.