LDL-Cholesterol

Primary DI

05204309122974

Basic UDI-DI Code

5204309000035NV

Reference

1419-0220

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 Low-Density Lipoprotein Cholesterol - LDL-C in samples of human serum or plasma from the general patient population. Measurements of LDL-Cholesterol are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for screening, diagnosis and management of atherosclerotic cardiovascular disease (ASCVD) risk assessment. This product has been packed for use with Diatron Pictus® P700/P500 or Medicon MEDILYZER® F/BX. For in vitro diagnostic use only by trained laboratory professionals.

The Basic UDI-DI associated with this device has 5 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).