GroundRules
21 CFR 862.1315: Galactose-1-phosphate uridyl transferase test system.
Where this section sits in the code
- 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
(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.
(b) Classification. Class II.
Collected 2026-08-27T02:24:47Z. Source file · JSON