{"data":{"id":"us/21-cfr-862.3050","jurisdiction":"us","citation":"21 CFR 862.3050","heading":"Breath-alcohol test system.","body":"(a) 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.\n(b) Classification. 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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart D—Clinical Toxicology Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"50b26830112f7f910a6956cb5205ee9ab2ff4721b6771cdcf629c51164cf4bf2","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.3040","next":"us/21-cfr-862.3080"},"notice":"GroundRules: Original legal text. Not legal advice."}