MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT

MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT is an FDA 510(k)-cleared medical device (K896641) manufactured by Medix Biotech, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 26, 1989. Regulation: 8.