21 C.F.R. § 866.5270

Current through October 31, 2024
Section 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).

21 C.F.R. §866.5270