HbA1c Assay kit CLIA

Primary DI

06974521001485

Basic UDI-DI Code

B-06974521001485

Reference

SUPM081072

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro quantitative detection of HbA1c in human whole blood. HbA1c is the main type of glycosylated hemoglobin in human blood, which is formed by non-enzymatic glycation of the free amino group at the N-terminal of hemoglobin A0β chain. Determination of HbA1c provides an important means to monitor dietary control and treatment effects during diabetes treatment. Diabetes treatment requires maintaining blood sugar as normal as possible for as long as possible to minimize the risk of long-term adverse vascular outcomes. Diabetes is a condition in which high blood sugar occurs when the body cannot use blood sugar to provide itself with energy. In type 1 diabetes, the pancreas no longer produces insulin, so blood sugar cannot enter the cells to be used for energy. In type 2 diabetes, the pancreas does not produce enough insulin or the body cannot use glucose properly. Detection and treatment of prediabetes can therefore reduce or eliminate the risk of type 2 diabetes and its associated complications. The determination of HbA1c can be used as an auxiliary diagnostic method for diabetes to monitor long-term glycemic control in patients with type 2 diabetes, and to identify patients at high risk of diabetes.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).