IVD Department Qualitative HBeAg Testing
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Nov 06, 2024- Analysis ID
- 2403388ĐKLH/BYT-HTTB
- Submission ID
- 18008057/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- Elecsys HBeAg: An in vitro immunoassay for the qualitative determination of the e antigen of hepatitis B virus (HBeAg) in human serum and plasma. The ECLIA (Electrochemiluminescence Immunoassay) is used in the Elecsys and cobase immunoassay systems.; PreciControl HBeAg: PreciControlHBeAg is used to control the quality of the ElecsysHBeAg immunoassay on the cobase immunoassay analyzer.
- Registration Date
- Nov 06, 2024
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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 2403388ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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