21 C.F.R. § 862.1315

Current through September 30, 2024
Section 862.1315 - Galactose-1-phosphate uridyl transferase test system
(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.

21 C.F.R. § 862.1315