
Terumo Medical Corp.
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SENSIBEAD EIA DIGOXIN KIT is an FDA 510(k)-cleared medical device (K840673) manufactured by Terumo Medical Corp.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 1984. Regulation: 8.