Qualitative Test for SARS-CoV-2 Antigen, Influenza A Virus, Influenza B Virus, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) - Vietnam Registration 2402945ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative Test for SARS-CoV-2 Antigen, Influenza A Virus, Influenza B Virus, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) 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 2402945ĐKLH/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
2402945ĐKLH/BYT-HTTB
000.00.04.G18-230304-0002
Respiratory Combo Antigen Rapid Test
GS110112C20
Technical Details
Respiratory Combo Antigen Rapid Test is a flow-through immunoassay intended for the qualitative detection and differentiation of nucleocapsid antigens of coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus, respiratory syncytial virus (RSV) and Adenovirus (ADV) directly from respiratory tract specimens obtained from individuals suspected of respiratory tract viral infection by the healthcare provider, within the first seven days of symptom onset.
Dates and Status
Oct 22, 2024