RF

Primary DI

05204309104345

Basic UDI-DI Code

5204309000039P5

Reference

1418-1030

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 Rheumatoid Factor -RF in samples of human serum from the general patient population. Measurements of RF are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid in the differential diagnosis, prognosis and management of rheumatoid arthritis in adult and juvenile patients. 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).