IVD Department Qualitative IgM Antibody to HBcAg Test
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Jun 24, 2024- Analysis ID
- 2400883ĐKLH/BYT-HTTB
- Submission ID
- 17005228/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ NHẬT ANH
- Intended Use
- LIAISON HBc IgM: The LIAISON HBc IgM test uses the CLIA (Chemiluminescent Immunoassay) technology to qualitatively determine the presence of IgM antibodies against the core antigen of the hepatitis B virus (IgM against HBc) in the blood serum or plasma sample. It is performed only on the LIAISON automated immunoassay analyzer. LIAISON Control HBc IgM: The LIAISON Control HBc IgM (negative and positive controls) are used in the CLIA (Chemiluminescent Immunoassay) LIAISON test to assess the reliability of the test runs. The performance characteristics of the LIAISON Control HBc IgM controls are not established for any other test or system except the LIAISON and LIAISON XL automated immunoassay analyzers.
- Registration Date
- Jun 24, 2024
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Access comprehensive regulatory information for IVD Department Qualitative IgM Antibody to HBcAg Test 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 2400883ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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