Vietnam MOH registration 2300891ĐKLH/BYT-HTTB

Qualitative Test for IgM and IgG Antibodies against Dengue in Whole Blood/Plasma/serum

VN: Khay thử xét nghiệm định tính kháng thể IgM, IgG kháng Dengue trong máu toàn phần/ huyết thanh/ huyết tương

Vietnam·Risk Class TTBYT Loại C·OnSite Dengue IgG/IgM Combo Rapid Test·Beijing Genesee Biotech, Inc.·Registered Sep 26, 2023

Registration details

Analysis ID: 2300891ĐKLH/BYT-HTTB
Submission ID: 19008940/ĐKLH-BYT-TB-CT
Product Type: OnSite Dengue IgG/IgM Combo Rapid Test
Product Code: R0061C

Company information

Manufacturer: Beijing Genesee Biotech, Inc.
Manufacturer Country: CHINA

Technical details

Intended Use: The test used to qualitatively detect the simultaneous presence and differentiate IgG and IgM antibodies against the Dengue virus (DEN1, 2, 3, 4) in serum, plasma, or whole blood of humans.

Dates and status

Registration Date: Sep 26, 2023

About this record

Access comprehensive regulatory information for Qualitative Test for IgM and IgG Antibodies against Dengue in Whole Blood/Plasma/serum 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 2300891ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc..

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