RUBELLA ELISA REAGENTS RUBELLA IGG ANTI

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI is an FDA 510(k)-cleared medical device (K802102) manufactured by Calbiochem-Behring Corp.. 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 17, 1980. Regulation: 8.