IVD Department Quantitative HbA1c Testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Wuxi Biohermes Bio & Medical Technology Co., Ltd·Registered May 28, 2024- Analysis ID
- 240001260/PCBB-HN
- Submission ID
- 000.00.19.H26-240523-0027
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Wuxi Biohermes Bio & Medical Technology Co., Ltd
- Authorized Representative
- CÔNG TY TNHH STV TECHNOLOGY
- Intended Use
- A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography) is used in conjunction with the A1cChek Pro HbA1c analyzer to measure the quantitative level of HbA1c in the whole blood. Glycohemoglobin Quality Control is used as a quality control material to monitor the accuracy of the HbA1c testing process and the quantitative HbA1c test kit by the boronate affinity chromatography method.
- Registration Date
- May 28, 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 TTBYT Loại B medical device is registered under number 240001260/PCBB-HN and manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH STV TECHNOLOGY.
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