D-DIMER

Primary DI

05204309086948

Basic UDI-DI Code

5204309000020NG

Reference

1418-1180

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagents for In Vitro quantitative automated determination of the concentration of D-Dimer in human plasma in the general patient population. Measurements of D-Dimer are intended to be used by licensed physicians, along with other in vitro and in vivo tests and physical examination as an aid for the detection and estimation of the severity of intravascular coagulation and fibrinolysis. Τhis 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 C) and regulation (EU IVDR).