GOAT ANTI-RUBELLA ANTISERA

GOAT ANTI-RUBELLA ANTISERA is an FDA 510(k)-cleared medical device (K780010) manufactured by Northeast Biomedical Labs., 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 January 19, 1978. Regulation: 8.