IVD Department Quantitative HbA1c Testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Registered Apr 03, 2024- Analysis ID
- 240000049/PCBB-BYT
- Submission ID
- 000.00.04.G18-240403-0001
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM
- Intended Use
- (1) HbA1c used in in vitro diagnosis when quantifying hemoglobin A1c (HbA1c) in the whole blood of the person performed on the Thermo Scientific™ Indiko™ and Konelab™. The results are used to monitor long-term blood glucose. Any reference to the Konelab system refers to the T series. (2) HbA1c Calibrator used in in vitro diagnosis as a reference calibrator for the quantitative determination of hemoglobin A1c (HbA1c) and hemoglobin (Hb) on the Indiko™ and Konelab™ clinical chemistry analyzers by the HbA1c process (codes 981947 and 981948) of Thermo™ Fisher Scientific Oy. Any reference to the Konelab system refers to the T series. (3) HbA1c Control Normal used in in vitro diagnosis as a concentration control material for the HbA1c test on the Konelab™ and Indiko™ clinical chemistry analyzers. Any reference to the Konelab system refers to the T series. (4) HbA1c Control Abnormal used in in vitro diagnosis as a concentration control material for the HbA1c test on the Konelab™ and Indiko™ clinical chemistry analyzers. Any reference to the Konelab system refers to the T series. (5) HbA1c Pretreatment Liquid used to dissolve whole blood for in vitro diagnostic tests to determine hemoglobin A1c (HbA1c) in human blood samples by the automated HbA1c processes of the Thermo Scientific™ Indiko™ and Konelab™. HbA1c Pretreatment Liquid is used with HbA1c test reagents (981947, 981948) for manual dissolution (Indiko, Konelab), and also as a concentration control 0 and for automatic dilution of HbA1c Calibrator. HbA1c Pretreatment Liquid is also used with HbA1c test reagents (981947, 981948) for the dissolution process on the machine (Konelab). All test results must be interpreted in the clinical context. Hemolyzing reagent and HbA1c Pretreatment Liquid are in vitro diagnostic (IVD) accessories.
- Registration Date
- Apr 03, 2024
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