
Medix Biotech, Inc.
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ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT is an FDA 510(k)-cleared medical device (K914756) 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 January 14, 1992. Regulation: 8.