IVD Department Qualitative HBeAg Testing
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Aug 30, 2024- Analysis ID
- 2402481ĐKLH/BYT-HTTB
- Submission ID
- 18007782/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- Intended Use
- - 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.
- Registration Date
- Aug 30, 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 2402481ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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