Khay thử xét nghiệm định tính kháng nguyên vi rút cúm A, vi rút cúm B - Vietnam Registration 2403546ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2403546ĐKLH/BYT-HTTB
000.00.04.G18-230304-0001
Theo theo phụ lục
Theo phụ lục
Technical Details
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.
Dates and Status
Nov 14, 2024