Qualitative Antibody Test for Syphilis - Vietnam Registration 2400617ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2400617ĐKLH/BYT-HTTB
000.00.04.G18-220609-0024
OnSite Syphilis Ab Combo Rapid Test
R0031C
Technical Details
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.
Dates and Status
May 10, 2024