Vietnam MOH registration 2402237ĐKLH/BYT-HTTB

Qualitative Antibody Test Card for Chikungunya (IgM, IgG)

VN: Thẻ xét nghiệm định tính kháng thể IgM, IgG kháng Chikungunya

Vietnam·Risk Class TTBYT Loại C·STANDARD™ F Chikungunya IgM/IgG FIA·SD Biosensor, Inc.·Registered Aug 27, 2024

Registration details

Analysis ID: 2402237ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231222-0035
Product Type: STANDARD™ F Chikungunya IgM/IgG FIA
Product Code: FCHK01B

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: 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

Registration Date: Aug 27, 2024

About this record

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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