Eu Ivdd Eu Ivd General On The Market

LP(a)

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05204309137091
Basic UDI-DI Code
B-05204309137091
Reference
1417-0530
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 Siemens ADVIA® 1800/2400/XPT series chemistry analyzers. For in vitro diagnostic use only by trained laboratory professionals.

CND Nomenclature Codes

Code Description
W0102010405 LIPOPROTEIN ( A )

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