N LATEX CYSTATIN C
Device Facts
| Record ID | K003503 |
|---|---|
| Device Name | N LATEX CYSTATIN C |
| Applicant | Dade Behring, Inc. |
| Product Code | NDY · Clinical Chemistry |
| Decision Date | Mar 13, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
