21 CFR § 862.1170 - Chloride test system.

---
identifier: "/us/cfr/t21/s862.1170"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1170 - Chloride test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1170"
section_name: "Chloride test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY 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: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1170 Chloride test system.

(a) *Identification.* A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

(b) *Classification.* Class II.