IGM

Primary DI

05204309167630

Basic UDI-DI Code

5204309000031NM

Reference

1415-0770

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 Immunoglobulin M – IgM in samples of human serum or plasma from the general patient population. Measurements of IgM are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for the assessment of immune status. 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 4 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).