
Medix Biotech, Inc.
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HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 is an FDA 510(k)-cleared medical device (K873872) 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 October 27, 1987. Regulation: 8.