Diagnostic Kit for HbA1c - India CDSCO Medical Device Registration

Diagnostic Kit for HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000169_98f08b07b2a9be34057b85c29934cc55_253111eedb148457d497ef212d1ae320. This device is marketed under the brand name Time-resolved Fluorescence Immunochromatographic Assay. The license holder is Arkray Healthcare 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

Diagnostic Kit for HbA1c

UID: IMP/IVD/2023/000169_98f08b07b2a9be34057b85c29934cc55_253111eedb148457d497ef212d1ae320

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

Arkray Healthcare Pvt., Ltd.,

Device Class

Class B

Approving Authority

CDSCO

Product Information

This test uses double antibody sandwich method principle and fluorescence immunochromatography analysis technology to quantitatively detect the concentration of HbA1c in human whole blood

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