URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
Device Facts
| Record ID | K001810 |
|---|---|
| Device Name | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING |
| Applicant | Flexsite Diagnostics, Inc. |
| Product Code | JIR · Clinical Chemistry |
| Decision Date | Aug 14, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1645 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
