AXSYM RUBELLA IGG ANTIBODY ASSAY

AXSYM RUBELLA IGG ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K954045) 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 23, 1996. Regulation: 8.