HbA1c

Primary DI

05204309167463

Basic UDI-DI Code

5204309000026NU

Reference

1415-1050

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 automated quantitative measurement by trained laboratory professionals of the concentration of HbA1c in samples of whole blood, from patients suspected for or diagnosed with diabetes. Measurements of HbA1c are intended to be used by licensed physicians, along with other in vitro and in vivo tests and physical examination, as an aid in the diagnosis of carbohydrate metabolism disorders such as diabetes and in monitoring of long-term glycemic control. This product has been packed for use with Abbott ARCHITECT® c4000/c8000/c16000 analyzers.

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 C) and regulation (EU IVDR).