21 CFR § 866.5660 - Multiple autoantibodies immunological test system.

---
identifier: "/us/cfr/t21/s866.5660"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5660 - Multiple autoantibodies immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5660"
section_name: "Multiple autoantibodies 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"
---


# 866.5660 Multiple autoantibodies immunological test system.

(a) *Identification.* A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

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