UIBC

Primary DI

05204309135332

Basic UDI-DI Code

5204309000045NY

Reference

1418-0280

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 determination of the concentration of Unsaturated Iron Binding Capacity – UIBC in samples of human serum or plasma from the general patient population. Measurements of UIBC are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for diagnosis and management of conditions related to iron metabolism. 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 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).