21 C.F.R. § 866.5400

Current through October 31, 2024
Section 866.5400 - Alpha-globulin immunological test system
(a)Identification. An alpha-globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9 .

21 C.F.R. §866.5400

47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312 , Jan. 14, 2000