{"data":{"id":"us/21-cfr-862.1050","jurisdiction":"us","citation":"21 CFR 862.1050","heading":"Alkaline phosphatase or isoenzymes test system.","body":"(a) Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal 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":"93398b58390f1ecc5aec5fdc205a6c840d63a10f845ab1233d434aa6da82d68f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1045","next":"us/21-cfr-862.1055"},"notice":"GroundRules: Original legal text. Not legal advice."}