GroundRules
21 CFR 866.5360: Cohn fraction IV immunological test system.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
- Subpart F—Immunological Test Systems
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON