21 CFR § 866.5400 - -globulin immunological test system.

---
identifier: "/us/cfr/t21/s866.5400"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5400 - -globulin immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5400"
section_name: "-globulin 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"
---


# 866.5400 -globulin immunological test system.

(a) *Identification.* An *alpha-*globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the *alpha-*globulin (a serum protein) in serum and other body fluids. Measurement of *alpha-*globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

(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 § 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]