SOPHEIA/MP CORTISOL EIA KIT

SOPHEIA/MP CORTISOL EIA KIT is an FDA 510(k)-cleared medical device (K850008) manufactured by Diagnostic Products Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 31, 1985. Regulation: 8.