IVD Department Qualitative HBeAg Testing - Vietnam Registration 2200190ĐKLH/BYT-TB-CT
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 2200190ĐKLH/BYT-TB-CT and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including 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
2200190ĐKLH/BYT-TB-CT
17003773/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
- ADVIA Centaur HBeAg: The ADVIA Centaur HBeAg test is an in vitro diagnostic immunoassay for the qualitative determination of the hepatitis B virus e antigen (HBeAg) in human serum and plasma, using the ADVIA Centaur CP, ADVIA Centaur XP and ADVIA Centaur XPT systems. This test is used in combination with other hepatitis B virus (HBV) marker tests to determine the clinical status of patients known to be infected with HBV. It is used as a supportive diagnostic tool in the evaluation of individuals with acute and chronic hepatitis B. - ADVIA Centaur QC HBeAg: To monitor the performance of the HBeAg test on the ADVIA Centaur systems. The performance of the HBeAg calibrator material has not been established for any other HBeAg test.
Dates and Status
Dec 27, 2022