21 CFR § 862.3040 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3040 Alcohol test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.3035 Amikacin test system.§ 862.3050 Breath-alcohol test system. →