HbA1c (AuraFIA HbA1c ) - India CDSCO Medical Device Registration

HbA1c (AuraFIA HbA1c ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000248_7623048dc144bce78bbfed1395722377_757eab4072dff41ac097c9befdca9d68. This device is marketed under the brand name Time-resolved Fluorescence Immunochromatographic Assay. The license holder is INDO-MIM TEC 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 (AuraFIA HbA1c )

UID: IMP/IVD/2022/000248_7623048dc144bce78bbfed1395722377_757eab4072dff41ac097c9befdca9d68

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of glycosylated hemoglobin(Time-resolved Fluorescence Immunochromatographic Assay) in human whole blood. This product is used for testing in medical and health institutions as an aid to monitor long-term glycemic status in patients with diabetes mellitus

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