UREA

Primary DI

05204309031245

Basic UDI-DI Code

5204309000046P2

Reference

1418-0027

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagent kit for In Vitro quantitative automated measurement by trained laboratory professionals of the concentration of urea in samples of human serum, plasma, or urine from patients from the general population. Measurements of urea are intended to be used by licensed physicians, along with other in vitro and in vivo tests and physical examination, as an aid in the assessment of kidney function and evaluation of conditions associated with azotemia. This product has been packed for use with BECKMAN COULTER AU series chemistry analyzers (AU600, AU600IVD, AU400, AU640, AU2700, AU5400, AU480, and AU680).

The Basic UDI-DI associated with this device has 3 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).