RF

Primary DI

05204309167678

Basic UDI-DI Code

5204309000039P5

Reference

1415-1030

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 Abbott ARCHITECT® c4000/c8000/c16000 analyzers. 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).