IVD Department qualitative test for specific IgM antibodies against HSV-1 and/or HSV-2 - Vietnam Registration 2400638ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department qualitative test for specific IgM antibodies against HSV-1 and/or HSV-2 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 2400638ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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Device Details
Registration Details
2400638ĐKLH/BYT-HTTB
18006167/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
1. LIAISON HSV-1/2 IgM: The LIAISON HSV-1/2 IgM test uses the CLIA (Chemiluminescent Immunoassay) technology to qualitatively detect the specific IgM antibodies against Herpes simplex virus type 1 and/or type 2 (HSV-1 and/or HSV-2) in human serum or plasma samples. The test is performed on the LIAISON automated immunoassay analyzer. 2. LIAISON Control HSV-1/2 IgM: The LIAISON Control HSV-1/2 IgM (negative and positive) materials are used in the CLIA (Chemiluminescent Immunoassay) to assess the reliability of the test runs. The performance characteristics of the LIAISON Control HSV-1/2 IgM materials are not established for any other test or system other than the LIAISON, LIAISON XL and LIAISON XS immunoassay analyzers.
Dates and Status
May 10, 2024