21 C.F.R. § 862.1315
Galactose-1-phosphate uridyl transferase test system.
Cite as 21 C.F.R. § 862.1315 (2026)
(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.