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/2020/000048_f0db786141f00b78e5b1a8873c63a7ff_da3cc13ee02f0ed283ee526731a76598. This device is marketed under the brand name NycoCard™ HbA1c. The license holder is Abbott Diagnostics Medical 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/2020/000048_f0db786141f00b78e5b1a8873c63a7ff_da3cc13ee02f0ed283ee526731a76598

Brand Name

NycoCard™ HbA1c

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (NycoCard™ HbA1c) in human whole blood

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