{"data":{"id":"us/21-cfr-862.1225","jurisdiction":"us","citation":"21 CFR 862.1225","heading":"Creatinine test system.","body":"(a) Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.\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":"4f5309faa8cd3e7c6acc898c4dbcc3f4e6e8dfd51941adfe123d42cb434daa4d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1223","next":"us/21-cfr-862.1230"},"notice":"GroundRules: Original legal text. Not legal advice."}