APO B

Primary DI

05204309071005

Basic UDI-DI Code

B-05204309071005

Reference

1418-0567

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Medicon Hellas SA

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 BECKMAN COULTER AU series chemistry analyzers (AU600, AU600IVD, AU400, AU640, AU2700, AU5400, AU480, and AU680). For in vitro diagnostic use only by trained laboratory professionals.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).