MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT

MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT is an FDA 510(k)-cleared medical device (K920253) manufactured by Medix Biotech, Inc.. 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 February 13, 1992. Regulation: 8.