EBV IgM Antibody Qualitative Test Control Reagent - Vietnam Registration 2301757ĐKLH/BYT-HTTB
Access comprehensive regulatory information for EBV IgM Antibody Qualitative Test Control Reagent in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2301757ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH.
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Device Details
Registration Details
2301757ĐKLH/BYT-HTTB
000.00.04.G18-221114-0008
Elecsys EBV IgM
08355258190
Technical Details
In vitro immunoassay for the qualitative determination of IgM antibodies against the Epstein-Barr virus (EBV) in human serum and plasma. This test is used in the support of diagnosis of monocytic leukemia associated with EBV infection and in determining the stage of EBV infection. The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") is used for the immunoassay cobas e.
Dates and Status
Dec 30, 2023