RUBELLA ANTIBODY FLUOROIMMUNOASSAY

RUBELLA ANTIBODY FLUOROIMMUNOASSAY is an FDA 510(k)-cleared medical device (K841174) manufactured by Intl. Diagnostic Technology. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 1984. Regulation: 8.