SOPHEIA DIGITOXIN EIA KIT & COMPONENTS

SOPHEIA DIGITOXIN EIA KIT & COMPONENTS is an FDA 510(k)-cleared medical device (K830035) manufactured by Diagnostic Products 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 January 27, 1983. Regulation: 8.