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/2022/000198_f0db786141f00b78e5b1a8873c63a7ff_003b6725f07c3b1fa293c8e598badfbb. This device is marketed under the brand name ichroma™ Myoglobin neo. The license holder is CPC DIAGNOSTICS 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

UID: IMP/IVD/2022/000198_f0db786141f00b78e5b1a8873c63a7ff_003b6725f07c3b1fa293c8e598badfbb

Brand Name

ichroma™ Myoglobin neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class B

Approving Authority

CDSCO

Product Information

EZ POC HbA1c is a fluorescence immunoassay (ichroma™ Myoglobin neo) for the quantitative determination of HbA1c (ichroma™ Myoglobin 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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Pricing

Promea Therapeutics Private Limited

Class B

Brand: ichroma™ Myoglobin neo

CPC DIAGNOSTICS PVT.LTD

Class B

Class A