{"data":{"id":"us/21-cfr-862.1035","jurisdiction":"us","citation":"21 CFR 862.1035","heading":"Albumin test system.","body":"(a) Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.\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":"f42080b04c9d94d017e473e266d6521fb048e44b79712bddb515a5f25acbd085","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1030","next":"us/21-cfr-862.1040"},"notice":"GroundRules: Original legal text. Not legal advice."}