
American Dade
Free shipping on orders over $99 · 30-day returns
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. is an FDA 510(k)-cleared medical device (K803045) manufactured by American Dade. 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 December 21, 1980. Regulation: 8.