{"data":{"id":"us/21-cfr-862.1310","jurisdiction":"us","citation":"21 CFR 862.1310","heading":"Galactose test system.","body":"(a) Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.\n(b) Classification. Class I.","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":"69b631d3cacef9a30361ac3240437fe04ad7eeb543db169d2894cee0152604db","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1305","next":"us/21-cfr-862.1315"},"notice":"GroundRules: Original legal text. Not legal advice."}