Khay thử xét nghiệm định tính kháng nguyên vi rút cúm A, vi rút cúm B
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·GeneSign Biotech (Xiamen) Co., Ltd·Registered Nov 14, 2024- Analysis ID
- 2403546ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230304-0001
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- GeneSign Biotech (Xiamen) Co., Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- GeneSign Biotech (Xiamen) Co., Ltd
- Authorized Representative
- CÔNG TY TNHH STV TECHNOLOGY
- Intended Use
- Influenza A/B Antigen Rapid Test is a flow-through immunoassay intended for in vitro diagnostic testing, to qualitatively detect and differentiate the nucleocapsid antigen from the influenza A and influenza B viruses directly from the nasopharyngeal swab specimen obtained from symptomatic patients suspected of being infected with the influenza A and/or B viruses by the healthcare provider.
- Registration Date
- Nov 14, 2024
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Access comprehensive regulatory information for Khay thử xét nghiệm định tính kháng nguyên vi rút cúm A, vi rút cúm B in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403546ĐKLH/BYT-HTTB and manufactured by GeneSign Biotech (Xiamen) Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH STV TECHNOLOGY.
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