
Genzyme Corp.
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ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR is an FDA 510(k)-cleared medical device (K021316) manufactured by Genzyme Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 24, 2002. Regulation: 8.