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Morax
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MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 is an FDA 510(k)-cleared medical device (K012789) manufactured by Morax. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 16, 2002. Regulation: 8.