21 CFR 862.1340 — Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1340
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 2 | 81 | 3rd Party |
| JIM | Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) | 2 | 2 | 3rd Party |
