Vietnam MOH registration 2400827ĐKLH/BYT-HTTB
Quantitative Antibody Test for IgM against the Core Antigen of Hepatitis B Virus (anti-HBc IgM)
VN: Bộ xét nghiệm định lượng kháng thể IgM kháng kháng nguyên lõi virus viêm gan B (anti-HBc IgM)
Vietnam·Risk Class TTBYT Loại D·VIDAS® HBc IgM II·BIOMERIEUX SA·Registered Jun 24, 2024Registration details
- Analysis ID
- 2400827ĐKLH/BYT-HTTB
- Submission ID
- 17002407/ĐKLH-BYT-TB-CT
- Product Type
- VIDAS® HBc IgM II
- Product Code
- 30439
Company information
- Manufacturer
- BIOMERIEUX SA
- Manufacturer Country
- FRANCE
- Product Owner
- BIOMERIEUX SA
- Authorized Representative
- CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM
Technical details
- Intended Use
- VIDAS® HBc IgM II is an automated quantitative test intended for use on VIDAS® devices to determine the presence of IgM antibodies against the core antigen of the hepatitis B virus (anti-HBc IgM) in human serum or plasma (EDTA, citrate and lithium heparin), using the ELFA (Enzyme-Linked Fluorescence Assay) technique. It is intended to be used in combination with the total anti-HBc antibody test to detect the presence of IgM antibodies against HBc in individuals suspected of being infected with the hepatitis B virus, thereby aiding in the diagnosis of hepatitis B virus infection.
Dates and status
- Registration Date
- Jun 24, 2024
About this record
Access comprehensive regulatory information for Quantitative Antibody Test for IgM against the Core Antigen of Hepatitis B Virus (anti-HBc IgM) 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 2400827ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.
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