Vietnam MOH registration 2400634ĐKLH/BYT-HTTB

IVD Department Qualitative Antibody Test for HDV

VN: Bộ IVD xét nghiệm định tính kháng thể kháng HDV

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

Registration details

Analysis ID: 2400634ĐKLH/BYT-HTTB
Submission ID: 19010414/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 Anti-HDV: The LIAISON XL murex Anti-HDV test uses the CLIA (Chemiluminescent Immunoassay) technology to determine the presence of antibodies against the hepatitis D virus (anti-HDV) in human serum and plasma samples, including samples obtained post-mortem (after cardiac arrest). The test is used to support the diagnosis of hepatitis D infection in individuals, whether symptomatic or asymptomatic. It is also used for screening of organ, tissue, or cell donors after death. The test is performed only on the LIAISON automated immunoassay instrument. LIAISON XL murex Control Anti-HDV: The LIAISON XL murex Control Anti-HDV (negative and positive controls) are used for CLIA (Chemiluminescent Immunoassay) LIAISON tests to assess the reliability of test runs. The performance characteristics of the LIAISON XL murex Control Anti-HDV controls have not been established for any other test or device except the LIAISON automated immunoassay instrument.

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for IVD Department Qualitative Antibody Test for HDV 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 2400634ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.