21 C.F.R. § 866.5160 Beta -globulin immunological test system.
Title 21 - Food and Drugs
(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. [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§ 866.5160
