IVD Department Qualitative HBeAg Testing - Vietnam Registration 2402481ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative HBeAg Testing 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 2402481ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo phụ lục, Theo theo phụ lục, and 2 recent registrations in the same category. 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.
Device Details
Registration Details
2402481ĐKLH/BYT-HTTB
18007782/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
- Atellica IM HBeAg: The Atellica IM Hepatitis B e Antigen (HBeAg) test is used for in vitro diagnosis to determine the presence of the e antigen of the hepatitis B virus (HBeAg) in human serum and plasma (EDTA, lithium heparin and sodium heparin) using the Atellica IM Analyzer and Atellica CI Analyzer. This test is used in conjunction with other hepatitis B virus (HBV) marker tests to determine the clinical status of patients known to be infected with HBV. The use of this test as a supportive diagnostic tool for acute and chronic hepatitis B cases. - Atellica IM HBeAg QC: The Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC) test is used for in vitro diagnosis to monitor the performance of the Atellica IM HBeAg test using the Atellica Immunoassay Analyzer.
Dates and Status
Aug 30, 2024