21 CFR § 866.5360 - Cohn fraction IV immunological test system.

---
identifier: "/us/cfr/t21/s866.5360"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5360 - Cohn fraction IV immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5360"
section_name: "Cohn fraction IV immunological test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 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.

[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]