21 CFR § 862.1315 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1315 Galactose-1-phosphate uridyl transferase test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1310 Galactose test system.§ 862.1320 Gastric acidity test system. →