HbA1c (AuraFIA HbA1c )
- UID
- IMP/IVD/2022/000248_7623048dc144bce78bbfed1395722377_757eab4072dff41ac097c9befdca9d68
- Device class
- Class B
- Brand name
- Time-resolved Fluorescence Immunochromatographic Assay
- License holder
- INDO-MIM TEC PRIVATE LIMITED
- 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
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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