21 C.F.R. § 866.5370 Cohn fraction V immunological test system.
Title 21 - Food and Drugs
(a) Identification. A Cohn fraction V immunological test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be depressed, e.g., nephrosis (disease of the kidney), proteinuria (protein in the urine), gastroenteropathy (disease of the stomach and small intestine), rheumatoid arthritis, and viral hepatitis. (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. [47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, 2001]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§ 866.5370 Cohn fraction V immunological test system.
