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e-CFR data is current as of July 7, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5600


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§866.5600   Low-density lipoprotein immunological test system.

(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).

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