21 C.F.R. § 862.1310 – Galactose test system. | Midpage
§ 862.1310
21 C.F.R. § 862.1310
Galactose test system.
(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.