Title 21

SECTION 862.1315

862.1315 Galactose-1-phosphate uridyl transferase test system.

§ 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.