CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
Device Facts
| Record ID | K904752 |
|---|---|
| Device Name | CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | JIR · Clinical Chemistry |
| Decision Date | Apr 12, 1991 |
| 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.
