DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT

DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT is an FDA 510(k)-cleared medical device (K943150) 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 March 14, 1995. Regulation: 8.