21 CFR § 862.1310 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1310 Galactose test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

(b) Classification. Class I.

← § 862.1305 Formiminoglutamic acid (FIGLU) test system.§ 862.1315 Galactose-1-phosphate uridyl transferase test system. →