CERA-STAT™ HbA1c Test Kit

Primary DI

08800065144402

Basic UDI-DI Code

B-08800065144402

Reference

CS400S10

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GC MEDIS Corp.

CERA-STAT™ HbA1c Test Kit can quantitatively measure HbA1c measurements and eAG(Estimated average glucose) results using the boronic acid reaction with glycated hemoglobin (HbA1c) in the blood of the patients who are concerned about diabetes. Glycated hemoglobin (HbA1c) is the combination of hemoglobin molecules in red blood cells that carry oxygen with glucose in the blood. It indicates the ratio of the glucose concentration in the blood and reflects the average blood glucose level for 2 to 3 months. It is used as the most useful and accurate marker.

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