MONOCLONAL ANTIBODY ANTI-CD3

MONOCLONAL ANTIBODY ANTI-CD3 is an FDA 510(k)-cleared medical device (K901189) manufactured by Sigma Chemical Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 1991. Regulation: 8.