21 CFR 862.1310 - Galactose test system.

Regulations last checked for updates: Feb 06, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 16122, May 1, 1987, unless otherwise noted.

cite as: 21 CFR 862.1310