IVD Department Qualitative Binding Assay for IgG Antibody Against Toxoplasma gondii - Vietnam Registration 2403730ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative Binding Assay for IgG Antibody Against Toxoplasma gondii in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403730ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403730ĐKLH/BYT-HTTB
000.00.04.G18-240913-0013
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys Toxo IgG Avidity: An in vitro immunoassay used to determine the avidity of IgG antibodies against Toxoplasma gondii in human serum and plasma. The ECLIA (electrochemiluminescence immunoassay “ECLIA”) is used for the cobas e immunoassay system. PreciControl Toxo IgG Avidity: PreciControl Toxo IgG Avidity is used to control the quality of the Elecsys Toxo IgG Avidity immunoassay on the cobas e immunoassay system.
Dates and Status
Nov 19, 2024