SOPHEIA/MP DIGITOXIN EIA KIT

SOPHEIA/MP DIGITOXIN EIA KIT is an FDA 510(k)-cleared medical device (K842578) 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 August 11, 1984. Regulation: 8.