HDL-Cholesterol

Primary DI

05204309086993

Basic UDI-DI Code

5204309000027NW

Reference

1418-0247

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagents for In Vitro quantitative automated measurement of the concentration of High-Density Lipoprotein Cholesterol - HDL-C in samples of human serum or plasma from the general patient population. Measurements of HDL-C are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as a direct and indirect aid for the preventative screening, risk assessment, diagnosis, and management 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.

The Basic UDI-DI associated with this device has 6 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).