G-6-PDH

Primary DI

05204309167500

Basic UDI-DI Code

5204309000023NN

Reference

1415-0910

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 measurement by trained laboratory professionals of the activity of the enzyme glucose-6-phosphate dehydrogenase (E.C. 1.1.1.49) in samples of whole blood, from newborn and individuals from the general population. Measurements of G6PDH are intended to be used by licensed physicians, along with other in vitro and in vivo tests and physical examination, as an aid in diagnosis of “G6PDH deficiency”. 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).