IVD Department Qualitative Antibody Test for Trypanosoma cruzi - Vietnam Registration 2403587ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative Antibody Test for Trypanosoma cruzi 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 2403587ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403587ĐKLH/BYT-HTTB
18008072/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys Chagas: An in vitro diagnostic test used to qualitatively determine antibodies against Trypanosoma cruzi (T. cruzi, the causative agent of Chagas disease) in human serum and plasma. The ECLIA (Electrochemiluminescence Immunoassay) test is used on the Elecsys and cobas e diagnostic platforms. PreciControl Chagas: PreciControl Chagas is used to monitor the quality of the Elecsys Chagas test on the Elecsys and cobas e diagnostic platforms.
Dates and Status
Nov 14, 2024