Drug test, qualitative antibody test for IgG and IgM against HBcAg
Vietnam·Risk Class TTBYT Loại D·Elecsys Anti-HBc II·Roche Diagnostics GmbH·Registered Jun 24, 2024- Analysis ID
- 2400838ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230823-0016
- Product Type
- Elecsys Anti-HBc II
- Product Code
- 09014926190
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer Country
- GERMANY
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- In vitro immunoassay for the qualitative determination of IgG and IgM antibodies against the core antigen of the hepatitis B virus in human serum and plasma. The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") is used for the cobas e immunoassay analyzers.
- Registration Date
- Jun 24, 2024
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Access comprehensive regulatory information for Drug test, qualitative antibody test for IgG and IgM against HBcAg 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 2400838ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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