{"data":{"id":"us/21-cfr-862.1315","jurisdiction":"us","citation":"21 CFR 862.1315","heading":"Galactose-1-phosphate uridyl transferase test system.","body":"(a) Identification. A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.\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":"cff0824a450d017671fdc85c2a8bfa7bf363cdb9553d3ac0c79e80aff105d601","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1310","next":"us/21-cfr-862.1320"},"notice":"GroundRules: Original legal text. Not legal advice."}