QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA

QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA is an FDA 510(k)-cleared medical device (K772422) manufactured by Bio-Rad. 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 February 12, 1978. Regulation: 8.