RUBELLA ANTIGEN AND CONTROL ANTIGEN

RUBELLA ANTIGEN AND CONTROL ANTIGEN is an FDA 510(k)-cleared medical device (K894262) manufactured by Microbix Biosystems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 1989. Regulation: 8.