Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05204309123063
- Basic UDI-DI Code
- B-05204309123063
- Reference
- 1419-0560
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Medicon Hellas SA
Additional Description
Reagents for In Vitro quantitative automated measurement of the concentration of Apolipoprotein B- Apo B in samples of human serum or plasma from the general patient population. Measurements of Apolipoprotein B are to be used along with other in vitro and in vivo tests and physical examination by licenced physicians, as an aid for screening, diagnosis, management, and risk assessment of atherosclerotic cardiovascular disease (ASCVD). This product has been packed for use with Diatron Pictus® P700/P500 or Medicon MEDILYZER® F/BX analyzers. For in vitro diagnostic use only by trained laboratory professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010403 | APOLIPOPROTEIN B |
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