HbA1c Reagent Kit (HbA1c Reagent Kit ) - India CDSCO Medical Device Registration

HbA1c Reagent Kit (HbA1c Reagent Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000305_de7a49c3f9c6c38fe5b1991ea0189b77_551a236ceb8b62188895858538f44d0e. This device is marketed under the brand name HbA1c Control Material. The license holder is Vector Biotek Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

HbA1c Reagent Kit (HbA1c Reagent Kit )

UID: IMP/IVD/2022/000305_de7a49c3f9c6c38fe5b1991ea0189b77_551a236ceb8b62188895858538f44d0e

Brand Name

HbA1c Control Material

License Holder

Vector Biotek Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The kit is used to quantitative determination of HbA1c content in the whole blood of human body with Lifotronic HbA1c/Hemoglobin Analyzer by high performance liquid chromatography (HbA1c Control Material) method. HbA1c has a stable structure, of which in vivo synthesis process is slow and irreversible. The synthesis rate of HbA1c is proportional to the concentration of blood glucose. It accumulates in the erythrocytes of 120 days lifetime. Therefore, the level of HbA1c reflects the average level of blood glucose in the past 2~3 months. It’s a reliable biomarker to indicate blood glucose levels.