IVD Department Qualitative HBeAg Testing
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 27, 2022- Analysis ID
- 2200190ĐKLH/BYT-TB-CT
- Submission ID
- 17003773/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- - 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.
- Registration Date
- Dec 27, 2022
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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.
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