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Stanbio Laboratory
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DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR is an FDA 510(k)-cleared medical device (K050266) manufactured by Stanbio Laboratory. 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 June 29, 2005. Regulation: 8.