HDL-Cholesterol

Primary DI

05204309167401

Basic UDI-DI Code

5204309000027NW

Reference

1415-0240

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 Abbott ARCHITECT® c4000/c8000/c16000 analyzers. 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).