21 C.F.R. § 862.1340

Current through November 30, 2024
Section 862.1340 - Urinary glucose (nonquantitative) test system
(a)Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
(b)Classification. Class II.

21 C.F.R. § 862.1340