IGE

Primary DI

05204309167661

Basic UDI-DI Code

5204309000029P2

Reference

1415-0800

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagent kit for In Vitro quantitative automated determination by trained laboratory professionals of the concentration of Immunoglobulin E – IgE in samples of human serum or plasma from the general patient population. Measurements of IgE 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 response to allergens and autoimmunity. This product has been packed for use with Abbott ARCHITECT® c4000/c8000/c16000 analyzers.

The Basic UDI-DI associated with this device has 6 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 C) and regulation (EU IVDR).