U/CSF Protein
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records โ and cites every one.
Free to try ยท every answer cites its records
Basic Information
- Primary DI
- 16438153818431
- Basic UDI-DI Code
- 6438153BU00057BW
- Reference
- 981843
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- 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 the total protein concentration in human urine and cerebrospinal fluid with the automated procedures of Thermo Scientificโข Indikoโข and Konelabโข analyzers. The urine protein test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of renal or pre-renal proteinuria, in patients. The cerebrospinal fluid (CSF) protein test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of hyperproteinemia, due to various neurological diseases, where total CSF protein levels are increased, in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010230 | TOTAL PROTEIN |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).