Qualitative Test for SARS-CoV-2 Antigen, Influenza A Virus, Influenza B Virus, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV)
Vietnam·Risk Class TTBYT Loại C·Respiratory Combo Antigen Rapid Test·GeneSign Biotech (Xiamen) Co., Ltd·Registered Oct 22, 2024- Analysis ID
- 2402945ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230304-0002
- Product Type
- Respiratory Combo Antigen Rapid Test
- Product Code
- GS110112C20
- Manufacturer
- GeneSign Biotech (Xiamen) Co., Ltd
- Manufacturer Country
- CHINA
- Product Owner
- GeneSign Biotech (Xiamen) Co., Ltd
- Authorized Representative
- CÔNG TY TNHH STV TECHNOLOGY
- Intended Use
- 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.
- Registration Date
- Oct 22, 2024
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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