21 C.F.R. § 866.5160

Current through September 30, 2024
Section 866.5160 - Beta-globulin immunological test system
(a)Identification. A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.
(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. §866.5160

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