CREATININE PLUS
Device Facts
| Record ID | K003261 |
|---|---|
| Device Name | CREATININE PLUS |
| Applicant | Roche Diagnostics Corp. |
| Product Code | JFY · Clinical Chemistry |
| Decision Date | Nov 16, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
