GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT

GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K822944) manufactured by Travenol Laboratories, S.A.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 29, 1982. Regulation: 8.