Regulations last checked for updates: Feb 11, 2026

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

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 862.1340