VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Device Facts
| Record ID | K001310 |
|---|---|
| Device Name | VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product Code | JFY · Clinical Chemistry |
| Decision Date | May 5, 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.
