21 CFR § 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).
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