21 CFR § 862.1340 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1340 Urinary glucose (nonquantitative) test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1335 Glucagon test system.§ 862.1345 Glucose test system. →