{"data":{"id":"us/21-cfr-862.1515","jurisdiction":"us","citation":"21 CFR 862.1515","heading":"Nitrogen (amino-nitrogen) test system.","body":"(a) Identification. A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.\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 B—Clinical Chemistry 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":"6da245e4d2ec71de913ad7358f4a220fb2a922e4293908662901f74cc57822ed","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1510","next":"us/21-cfr-862.1520"},"notice":"GroundRules: Original legal text. Not legal advice."}