MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT

MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT is an FDA 510(k)-cleared medical device (K903359) manufactured by Immunotech Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 21, 1990. Regulation: 8.