CHOLESTEROL
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
- 16438153007774
- Basic UDI-DI Code
- 6438153BU00200BB
- Reference
- 981957
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Thermo Fisher Scientific Oy
Additional Description
For in vitro diagnostic use in the quantitative determination of cholesterol concentration in human serum and plasma with the automated procedures of Thermo Scientificโข Indikoโข and Konelabโข analyzers. The Cholesterol test is indicated to be used in conjunction with clinical evaluation for prediction of coronary heart disease, in patients. Furthermore, the Cholesterol test is indicated to be used in conjunction with clinical evaluation for screening for atherosclerosis risk and for aid to diagnosis of lipid and lipoprotein metabolism disorders, in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010205 | CHOLESTEROL |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).