Vietnam MOH registration 2400528ĐKLH/BYT-HTTB

IVD Department quantitative IgG antibody against CMV

VN: Bộ IVD xét nghiệm định lượng kháng thể IgG kháng CMV

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Apr 10, 2024

Registration details

Analysis ID: 2400528ĐKLH/BYT-HTTB
Submission ID: 18006229/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH THIẾT BỊ NHẬT ANH

Technical details

Intended Use: LIAISON CMV IgG II: The LIAISON CMV IgG II test uses the CLIA (Chemiluminescent Immunoassay) technology to quantify the specific IgG antibodies against hCMV (Human Cytomegalovirus) in human serum or plasma samples. It is performed on the LIAISON automated immunoassay analyzer. LIAISON Control CMV IgG II: The LIAISON Control CMV IgG II (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 CMV IgG II controls are not established for any other test or system other than the LIAISON, LIAISON XL and LIAISON XS immunoassay analyzers.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative IgG antibody against CMV 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 2400528ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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