Vietnam MOH registration 2400523ĐKLH/BYT-HTTB

IVD Department Qualitative Antibody Test for HTLV-I/II

VN: Bộ IVD xét nghiệm định tính kháng thể kháng HTLV-I/II

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

Registration details

Analysis ID: 2400523ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211124-0004
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 recHTLV-I/II: The LIAISON XL murex recHTLV-I/II test uses CLIA (Chemiluminescent Immunoassay) technology to qualitatively detect antibodies specific to the virus that causes acute T-cell lymphotropic leukemia in humans (Human T-cell Lymphotropic Virus - HTLV) type I and/or type II in human serum or plasma, including samples taken post-mortem (cardiac arrest). The test is used to support the diagnosis of HTLV-I/II infection in individuals, whether symptomatic or asymptomatic. The test is also used to screen blood donors and blood components, as well as organ, tissue, and cellular donors post-mortem. The test is performed only on the LIAISON XL automated immunoassay instrument. LIAISON XL murex Control recHTLV-I/II: The LIAISON XL murex Control recHTLV-I/II (negative and positive) materials are used as quality control samples to monitor the performance and reliability of the LIAISON XL murex recHTLV-I/II test. The performance characteristics of LIAISON XL murex Control recHTLV-I/II have not been established for any other test or instrument system other than the LIAISON XL automated immunoassay instrument.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for IVD Department Qualitative Antibody Test for HTLV-I/II 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 2400523ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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