Qualitative Antibody Test Card for Chikungunya (IgM, IgG) - Vietnam Registration 2402237ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative Antibody Test Card for Chikungunya (IgM, IgG) 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 2402237ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
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Device Details
Registration Details
2402237ĐKLH/BYT-HTTB
000.00.04.G18-231222-0035
STANDARD™ F Chikungunya IgM/IgG FIA
FCHK01B
Technical Details
STANDARD™ F Chikungunya IgM/IgG FIA is a fluorescent immunoassay for the detection of Chikungunya virus-specific IgM/IgG antibodies in serum, plasma, and whole blood samples from humans. This test is intended for in vitro diagnostic use only. This test is intended for professional use only and is not recommended for screening purposes. The results of the kit must be interpreted using the appropriate analyzer, the STANDARD™ F Analyzer, manufactured by SD Biosensor.
Dates and Status
Aug 27, 2024