21 CFR 862.3050 — Devices, Breath Trapping, Alcohol

Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3050

Identification

A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DJZDevices, Breath Trapping, Alcohol128
Innolitics

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