21 C.F.R. § 862.3220 Carbon monoxide test system.
Title 21 - Food and Drugs
(a) Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning. (b) Classification. Class I.
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D—Clinical Toxicology Test Systems
§ 862.3220 Carbon monoxide test system.

