Qualitative Fluorescent Test Card for Influenza A and B Viral Antigen - Vietnam Registration 2402217ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative Fluorescent Test Card for Influenza A and B Viral Antigen 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 2402217ĐKLH/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
2402217ĐKLH/BYT-HTTB
19009095/ĐKLH-BYT-TB-CT
STANDARD™ F Influenza A/B FIA
FINF01G
Technical Details
The STANDARD™ F Influenza A/B FIA test is a fluorescent immunoassay for the detection of flu virus infection in specimens such as nasal swab, nasopharyngeal swab, aspirate, or wash fluid from the nasopharynx, by determining the presence of the nucleoprotein antigens of flu A and flu B viruses. The STANDARD™ F Influenza A/B FIA kit is used with the STANDARD™ F Analyzers manufactured by SD BIOSENSOR. This kit is intended for professional use and is only a preliminary screening test.
Dates and Status
Aug 27, 2024