IVD Department Quantitative HbA1c Testing
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Registered Nov 20, 2024- Analysis ID
- 240002663/PCBB-HCM
- Submission ID
- 000.00.19.H29-241015-0008
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH
- Intended Use
- *) HbA1c (Product Code: 981947; 981948): For use in in vitro diagnostic testing to determine the relative concentration of hemoglobin A1c (HbA1c) in the blood of a human, which has been lysed by an automated process of the Thermo Scientific™ Indiko™ and Konelab™ analyzers. The HbA1c test is intended to be used in combination with clinical evaluation to support the diagnosis of diabetes and to monitor the blood glucose levels of patients over time. Furthermore, the HbA1c test is intended to be used in combination with clinical evaluation to assess the response to diabetes treatment and to predict the development of microvascular complications in patients. *) HbA1c Calibrator (Product Code: 981863): The HbA1c Calibrator is used as a reference standard for in vitro diagnostic tests to determine hemoglobin A1c (HbA1c) and hemoglobin (Hb) in samples from humans by the HbA1c automatic process of the Thermo Scientific™ Indiko™ and Konelab™ analyzers. *) HbA1c Control Normal (Product Code: 981695): The HbA1c Control Normal is used to control the accuracy of in vitro diagnostic tests to determine hemoglobin A1c (HbA1c) and hemoglobin (Hb) in samples from humans by the HbA1c automatic process of the Thermo Scientific™ Indiko™ and Konelab™ analyzers. *) HbA1c Control Abnormal (Product Code: 981696): The HbA1c Control Abnormal is used to control the accuracy of in vitro diagnostic tests to determine hemoglobin A1c (HbA1c) and hemoglobin (Hb) in samples from humans by the HbA1c automatic process of the Thermo Scientific™ Indiko™ and Konelab™ analyzers. *) Hemolyzing Reagent (Product Code: 981659) and HbA1c Pretreatment Liquid (Product Code: 981924): The Hemolyzing Reagent and HbA1c Pretreatment Liquid are used to lyse whole blood for in vitro diagnostic tests to determine hemoglobin A1c (HbA1c) in human blood samples by the HbA1c automatic process of the Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Hemolyzing Reagent and HbA1c Pretreatment Liquid are used with the HbA1c tests (981947, 981948) for manual lysis (Indiko, Konelab), and also as a zero standard and for automatic dilution of the HbA1c Calibrator. The HbA1c Pretreatment Liquid is also used with the HbA1c tests (981947, 981948) for the manual lysis process (Konelab). All test results must be interpreted in the clinical context. The Hemolyzing Reagent and HbA1c Pretreatment Liquid are accessories for IVD.
- Registration Date
- Nov 20, 2024
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Access comprehensive regulatory information for IVD Department Quantitative HbA1c Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002663/PCBB-HCM. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.
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