HbA1c - India CDSCO Medical Device Registration

HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000056_f0db786141f00b78e5b1a8873c63a7ff_b405efa16fabf30bc4b26f4baacb20a2. This device is marketed under the brand name ichroma™ Vitamin D Neo. The license holder is M/s SPARK SCIENTIFIC PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

HbA1c

UID: IMP/IVD/2023/000056_f0db786141f00b78e5b1a8873c63a7ff_b405efa16fabf30bc4b26f4baacb20a2

Brand Name

ichroma™ Vitamin D Neo

License Holder

M/s SPARK SCIENTIFIC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

ichroma™ HbA1c Neo is a fluorescence Immunoassay (ichroma™ Vitamin D Neo) for the quantitative determination of HbA1c (ichroma™ Vitamin D Neo) in human whole blood. It is useful as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus.

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