Diagnostic Kit for HbA1c (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521000648

Basic UDI-DI Code

B-06974521000648

Reference

SUPF024025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is suitable for in vitro quantitative detection of the concentration of glycosylated hemoglobin(HbA1c) in human whole blood. This product is used for testing in medical and health institutions as an aid to monitor long-term glycemic status in patients with diabetes mellitus. Glycosylated hemoglobin(HbA1c) is a product where glucose in the blood in combination with the hemoglobin of red blood cells. Because the degradation process is very slow, the amount of production is no longer dissociated, and is not affected by the temporary increase of blood sugar, therefore, glycosylated hemoglobin has special diagnostic value for hyperglycemia, especially the large fluctuation of blood sugar. The content of glycosylated hemoglobin in the whole blood can reflect the average blood glucose level in the first 8-12 weeks at the time of detection, reflect the level of glucose metabolism in the body and the degree of diabetes control, and have positive clinical significance for the clinical diagnosis, screening, judgment of chronic complications and medication adjustment of diabetes mellitus.

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