21 C.F.R. § 862.1310

Current through August 31, 2024
Section 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.
(b)Classification. Class I.

21 C.F.R. § 862.1310