HbA1c Control - India CDSCO Medical Device Registration

HbA1c Control is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000048_29ad24a3e57465047ef8acf56cd969aa_8247fd918287458212a5f6551a070513. 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 Control

UID: IMP/IVD/2020/000048_29ad24a3e57465047ef8acf56cd969aa_8247fd918287458212a5f6551a070513

Brand Name

NycoCard™ HbA1c

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Afinion™ HbA1c Control kit contains liquid preparations of stabilized porcine whole blood (NycoCard™ HbA1c) and human whole blood (NycoCard™ HbA1c), respectively

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