IVD Department Quantitative HbA1c Testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 06, 2023- Analysis ID
- 230002725/PCBB-HCM
- Submission ID
- 000.00.19.H29-231123-0017
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- -HbA1c Quantitative Test: Used for in vitro testing to determine the concentration of HbA1c in the whole blood - HbA1c Quantitative Test Calibration Standard: Used for in vitro testing to use the calibration procedure to determine the concentration of hemoglobin A1c (HbA1c) in blood in the form of blood for each automated method. - HbA1c Quantitative Test Control Material: Used for in vitro testing to use the quality control procedure to determine the concentration of hemoglobin A1c (HbA1c) in blood A1c (HbA1c) in blood for each automated turbidity measurement method.
- Registration Date
- Dec 06, 2023
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