Diagnostic Kit for HbA1c - India CDSCO Medical Device Registration

Diagnostic Kit for HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000208_b6ea0de38c0f2052b10c2f561bdd42ba_6a088bdb72670bd068118d84131c2a0f. This device is marketed under the brand name MyBox HbA1c. The license holder is Mylab Discovery Solutions 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

Diagnostic Kit for HbA1c

UID: IMP/IVD/2023/000208_b6ea0de38c0f2052b10c2f561bdd42ba_6a088bdb72670bd068118d84131c2a0f

Brand Name

MyBox HbA1c

License Holder

Mylab Discovery Solutions Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of glycosylated hemoglobin (MyBox 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