Vietnam MOH registration 2403207ĐKLH/BYT-HTTB

Qualitative Test for IgM and IgG Antibodies against Dengue

VN: Khay thử xét nghiệm định tính kháng thể IgM, IgG kháng Dengue
Vietnam flagVietnam·Risk Class TTBYT Loại C·Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)·Zhejiang Orient Gene Biotech Co.,Ltd.·Registered Nov 02, 2024
Registration details
Analysis ID
2403207ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-240802-0003
Product Type
Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)
Product Code
GCDEN(ab)-402c
Company information
Manufacturer Country
CHINA
Product Owner
Zhejiang Orient Gene Biotech Co., Ltd.
Authorized Representative
CÔNG TY TNHH AVANTA DIAGNOSTICS
Technical details
Intended Use
Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for qualitative detection of Dengue virus-specific IgG and IgM antibodies in whole blood, serum, or plasma, to assist in the diagnosis of primary and secondary Dengue infection.
Dates and status
Registration Date
Nov 02, 2024
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About this record

Access comprehensive regulatory information for Qualitative Test for IgM and IgG Antibodies against Dengue 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 2403207ĐKLH/BYT-HTTB and manufactured by Zhejiang Orient Gene Biotech Co.,Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Beijing Genesee Biotech, Inc., and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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