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Corgenix, Inc.
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REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT is an FDA 510(k)-cleared medical device (K001352) manufactured by Corgenix, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 8, 2001. Regulation: 8.