§ 866.5600. Low-density lipoprotein immunological test system.
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/us/cfr/t21/s§ 866.5600·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid
(fat)metabolism and help to identify young persons at risk from cardiovascular diseases.
(b)Classification. Class II (performance standards).