IMX RUBELLA IGM ANTIBODY ASSAY

IMX RUBELLA IGM ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K931059) 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 December 18, 1994. Regulation: 8.