21 CFR § 862.3040 - Alcohol test system.

---
identifier: "/us/cfr/t21/s862.3040"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3040 - Alcohol test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3040"
section_name: "Alcohol 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"
---


# 862.3040 Alcohol test system.

(a) *Identification.* An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

(b) *Classification.* Class II.