§ 866.5160. Beta-globulin immunological test system.
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/us/cfr/t21/s§ 866.5160·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]