HbA1c(HbA1c Fast Test Kit ) - India CDSCO Medical Device Registration

HbA1c(HbA1c Fast Test Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000016_f1f055caa7f870e9cbf884d17889892e_db845e5a6f9aef5e67c9b1c30259d077. This device is marketed under the brand name Immunofluorescence Assay. The license holder is Akshat Bio Medicals 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(HbA1c Fast Test Kit )

UID: IMP/IVD/2021/000016_f1f055caa7f870e9cbf884d17889892e_db845e5a6f9aef5e67c9b1c30259d077

Brand Name

Immunofluorescence Assay

License Holder

Akshat Bio Medicals Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

HbA1c fast test kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of HbA1c in whole blood. This test is used as an aid for monitoring glycemic control in diabetics. In addition it can identify people at risk of developing the diseases and ongoing monitoring