Test for HbA1c - India CDSCO Medical Device Registration

Test for HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000618_8adb2dcfef0129adf6b0516c0981aba7_d284f77bd039333518d8dad89e28b4c2. This device is marketed under the brand name ichroma™ Cystatin C. The license holder is KABS HEALTHCARE 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

Test for HbA1c

UID: IMP/IVD/2020/000618_8adb2dcfef0129adf6b0516c0981aba7_d284f77bd039333518d8dad89e28b4c2

Brand Name

ichroma™ Cystatin C

License Holder

KABS HEALTHCARE PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

ichroma™ HbA1c is a fluorescence Immunoassay (ichroma™ Cystatin C) for the quantitative determination of HbA1c(ichroma™ Cystatin C) 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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Test for HbA1c

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DiaSys Diagnostics India Private Limited

Test for HbA1c - India CDSCO Medical Device Registration

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