
Sangui Biotech, Inc.
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CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY is an FDA 510(k)-cleared medical device (K001943) manufactured by Sangui Biotech, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 22, 2000. Regulation: 8.