21 C.F.R. § 866.5360

Current through October 31, 2024
Section 866.5360 - Cohn fraction IV immunological test system
(a)Identification. A Cohn fraction IV immunological test system is a device that consists of or measures that fraction of plasma proteins, predominantly alpha- and beta- globulins, used as a raw material for the production of pure alpha- or beta- globulins. Measurement of specific alpha- or beta- globulins aids in the diagnosis of many diseases, such as Wilson's disease (an inherited disease affecting the liver and brain), Tangier's disease (absence of alpha-1-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease.
(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 the limitations in § 866.9 .

21 C.F.R. §866.5360

47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38793 , July 25, 2001