TERUMO SENSIBEAD EIA TSH KIT

TERUMO SENSIBEAD EIA TSH KIT is an FDA 510(k)-cleared medical device (K850376) manufactured by Terumo Medical Corp.. 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 March 3, 1985. Regulation: 8.