Vietnam MOH registration 2400527ĐKLH/BYT-HTTB

IVD Department quantitative IgM specific antibody test for Toxoplasma gondii

VN: Bộ IVD xét nghiệm định lượng kháng thể IgM đặc hiệu với Toxoplasma gondii

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

Registration details

Analysis ID: 2400527ĐKLH/BYT-HTTB
Submission ID: 18007033/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 Toxo IgM: The LIAISON Toxo IgM test uses the CLIA (Chemiluminescent Immunoassay) technology to quantify the specific IgM antibodies against Toxoplasma gondii in human serum or plasma samples. The test is performed on the LIAISON automated immunoassay analyzer. LIAISON Control Toxo IgM: The LIAISON Control Toxo 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 Toxo IgM control material have not been established for any other test or system except the LIAISON, LIAISON XL and LIAISON XS automated immunoassay analyzers.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative IgM specific antibody test for Toxoplasma gondii 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 2400527ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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