DIA SCREEN REAGENT STRIPS
Device Facts
| Record ID | K952971 |
|---|---|
| Device Name | DIA SCREEN REAGENT STRIPS |
| Applicant | Genesis Labs, Inc. |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Aug 11, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
Regulatory Classification
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.
