Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05204309168217
- Basic UDI-DI Code
- B-05204309168217
- Reference
- 1415-0530
- 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 Lipoprotein (a) - Lp(a) in samples of human serum or plasma from the general patient population. Measurements of Lp(a) are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid in the stratification and reclassification of genetically determined lifelong risk associated with the development of cardiovascular diseases. This product has been packed for use with Abbott ARCHITECT® c4000/c8000/c16000 analyzers. For in vitro diagnostic use only by trained laboratory professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010405 | LIPOPROTEIN ( A ) |
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