Apolipoprotein A1
Basic Information
- Primary DI
- 16438153819292
- Basic UDI-DI Code
- 6438153BU00173BZ
- Reference
- 981929
- 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 apolipoprotein A1 (Apo A1) concentration in human serum and plasma with the automated procedures of Thermo Scientificโข Indikoโข and Konelabโข analyzers. The Apolipoprotein A1 test, in combination with the apolipoprotein B (Apo B) test, is indicated to be used in conjunction with clinical evaluation for prediction of the risk for coronary heart disease and atherosclerosis, in patients. The Apolipoprotein A1 test is furthermore indicated to be used in conjunction with clinical evaluation for aid to diagnosis of dyslipidemia, in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010401 | APOLIPOPROTEIN A I |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).