IVD Department Qualitative Antibody Against Hepatitis B Virus Antigen Test - Vietnam Registration 2402551ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative Antibody Against Hepatitis B Virus Antigen Test 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 2402551ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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Device Details
Registration Details
2402551ĐKLH/BYT-HTTB
18007773/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
- Atellica IM aHBe2: The Atellica IM Anti-HBe2 (aHBe2) test is an in vitro diagnostic immunoassay for the qualitative detection of antibodies against the e-antigen of the hepatitis B virus (HBV) in children (2-21 years of age) and in EDTA-anticoagulated blood plasma or lithium heparin-anticoagulated blood plasma of adults, who are suspected of being infected with HBV or have risk factors for HBV infection or are known to be infected with HBV. The result of this test, combined with other diagnostic information, can be used to support the determination of the clinical status of HBV or the management of HBV. - Atellica IM aHBe2 QC: The Atellica IM Anti-HBe2 Quality Control (aHBe2 QC) is used for in vitro diagnostic monitoring of the performance of the Atellica IM Anti-HBe2 (aHBe2) test using the Atellica IM analyzer.
Dates and Status
Aug 30, 2024