21 C.F.R. § 866.5270 C-reactive protein immunological test system.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§ 866.5270 C-reactive protein immunological test system.
