Vietnam MOH registration 2402217ĐKLH/BYT-HTTB

Qualitative Fluorescent Test Card for Influenza A and B Viral Antigen

VN: Thẻ xét nghiệm định tính kháng nguyên vi rút cúm A, cúm B

Vietnam·Risk Class TTBYT Loại C·STANDARD™ F Influenza A/B FIA·SD Biosensor, Inc.·Registered Aug 27, 2024

Registration details

Analysis ID: 2402217ĐKLH/BYT-HTTB
Submission ID: 19009095/ĐKLH-BYT-TB-CT
Product Type: STANDARD™ F Influenza A/B FIA
Product Code: FINF01G

Company information

Manufacturer: SD Biosensor, Inc.
Manufacturer Country: REPUBLIC OF
Product Owner: SD Biosensor, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH

Technical details

Intended Use: 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

Registration Date: Aug 27, 2024

About this record

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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