{"data":{"id":"us/21-cfr-862.1770","jurisdiction":"us","citation":"21 CFR 862.1770","heading":"Urea nitrogen test system.","body":"(a) Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.\n(b) Classification. Class II.","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":"083ff17e23cb5d53b83a40539963fbd055f5ab5557c7424ea2e2dceb3b4bbcb7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1730","next":"us/21-cfr-862.1775"},"notice":"GroundRules: Original legal text. Not legal advice."}