Vietnam MOH registration 2400638ĐKLH/BYT-HTTB

IVD Department qualitative test for specific IgM antibodies against HSV-1 and/or HSV-2

VN: Bộ IVD xét nghiệm định tính kháng thể IgM đặc hiệu với HSV-1 và/hoặc HSV-2

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

Registration details

Analysis ID: 2400638ĐKLH/BYT-HTTB
Submission ID: 18006167/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: 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

Registration Date: May 10, 2024

About this record

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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