21 CFR § 866.5880 - Transferrin immunological test system.

---
identifier: "/us/cfr/t21/s866.5880"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5880 - Transferrin immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5880"
section_name: "Transferrin 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"
---


# 866.5880 Transferrin immunological test system.

(a) *Identification.* A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

(b) *Classification.* Class II (performance standards).