Title 21: Food and Drugs
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/ PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
/ Subpart F - Immunological Test Systems / § 866.5270 C-reactive protein immunological test system.
§ 866.5270 C-reactive protein immunological test system.
(a) Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
(b) Classification. Class II (performance standards).