HbA1c

Primary DI

16438153002403

Basic UDI-DI Code

6438153BU00022BB

Reference

981948

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

For in vitro diagnostic use in the quantitative determination of relative hemoglobin A1c (HbA1c) concentration in hemolyzed human blood with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The HbA1c test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of diabetes mellitus and long-term monitoring of glycemia, in patients. Furthermore, the HbA1c test is indicated to be used in conjunction with clinical evaluation for assessing response to diabetes treatment and for predicting the development of microvascular complications, in patients.

The Basic UDI-DI associated with this device has 2 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).