Qualitative Antibody Test for Syphilis
Vietnam·Risk Class TTBYT Loại D·OnSite Syphilis Ab Combo Rapid Test·Beijing Genesee Biotech, Inc.·Registered May 10, 2024- Analysis ID
- 2400617ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220609-0024
- Product Type
- OnSite Syphilis Ab Combo Rapid Test
- Product Code
- R0031C
- Manufacturer
- Beijing Genesee Biotech, Inc.
- Manufacturer Country
- CHINA
- Product Owner
- CTK Biotech, Inc.
- Authorized Representative
- CÔNG TY TNHH AVANTA DIAGNOSTICS
- Intended Use
- OnSite Syphilis Ab Combo Rapid Test is an immunoassay test device, based on the principle of unidirectional flow, for qualitative detection of Treponema pallidum (Tp) antibodies (IgG, IgM and IgA) in human serum, plasma or whole blood. It is used for screening and supporting the diagnosis of Tp infection. Any use or interpretation of the results from this preliminary test must be based on clinical manifestations and professional medical diagnosis. Other testing methods must be used to confirm the results obtained from this test kit.
- Registration Date
- May 10, 2024
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Access comprehensive regulatory information for Qualitative Antibody Test for Syphilis in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2400617ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.
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