Creatinine (Jaffé)
Basic Information
- Primary DI
- 16438153818103
- Basic UDI-DI Code
- 6438153BU00131BH
- Reference
- 981810
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Thermo Fisher Scientific Oy
Additional Description
INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of creatinine concentration (Jaffé reaction) in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Creatinine (Jaffé) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of acute and chronic renal insufficiency, in patients. Furthermore, the Creatinine (Jaffé) test is also indicated to be used in calculation of glomerular filtration rate (GFR) in order to evaluate kidney function in patients with chronic kidney disease (CKD) or in patients at risk of CKD. The Creatinine (Jaffé) urine test is indicated to be used in conjunction with drug of abuse tests for identification of urine water content and a possible manipulation of a urine specimen used for drug urine screening.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010207 | CREATININE |
Available In Countries
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Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).