Vietnam MOH registration 2400227ĐKLH/BYT-HTTB

IVD Department qualitative test for the p24 antigen of HIV-1, HIV-1 (M, O) antibodies and/or HIV-2 antibodies

VN: Bộ IVD xét nghiệm định tính kháng nguyên p24 của HIV-1, kháng thể kháng HIV-1 (nhóm M, O) và/hoặc kháng thể kháng HIV-2

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Feb 04, 2024

Registration details

Analysis ID: 2400227ĐKLH/BYT-HTTB
Submission ID: 18006867/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 XL murex HIV Ab/Ag HT: The LIAISON XL murex HIV Ab/Ag HT test uses the CLIA (Chemiluminescent Immunoassay) technology to qualitatively determine the p24 antigen of the Human Immunodeficiency Virus type 1 (HIV-1) and quantitatively determine the specific antibodies against both types of HIV-1 (group M and group O) and/or type 2 (HIV-2) in human serum or plasma. The LIAISON XL murex HIV Ab/Ag HT test is used in the diagnosis of HIV-1/ HIV-2 infection and in the screening of blood or plasma donors. The test is performed only on the LIAISON XL automated immunoassay instrument. LIAISON XL murex Control HIV Ab/Ag HT: The LIAISON XL murex Control HIV Ab/Ag HT (negative and positive for HIV-1 antibodies and p24 antigen of HIV) is used in the CLIA (Chemiluminescent Immunoassay) LIAISON test to assess the reliability of test runs. The performance characteristics of the LIAISON XL murex Control HIV Ab/Ag HT have not been established for any other test or system other than the LIAISON XL automated immunoassay instrument.

Dates and status

Registration Date: Feb 04, 2024

About this record

Access comprehensive regulatory information for IVD Department qualitative test for the p24 antigen of HIV-1, HIV-1 (M, O) antibodies and/or HIV-2 antibodies 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 2400227ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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