Vietnam MOH registration 2401184ĐKLH/BYT-HTTB

Qualitative RNA Test for SARS-CoV-2

VN: Thuốc thử xét nghiệm định tính RNA của SARS-CoV-2
DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit
Vietnam flagVietnam·Risk Class TTBYT Loại C·DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit·SolGent Co., Ltd.·Registered Jul 22, 2024
Registration details
Analysis ID
2401184ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-220908-0001
Product Type
DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit
Product Code
SQD52-K100
Company information
Manufacturer
SolGent Co., Ltd.
Manufacturer Country
REPUBLIC OF
Product Owner
SolGent Co., Ltd.
Technical details
Intended Use
DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit is a real-time reverse transcriptase (RT)-PCR based test kit to qualitatively detect the nucleic acid of SARS-CoV-2 virus in the nasopharyngeal swab, oropharyngeal swab, and sputum samples from individuals suspected of being infected with COVID-19.
Dates and status
Registration Date
Jul 22, 2024
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About this record

Access comprehensive regulatory information for Qualitative RNA Test for SARS-CoV-2 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 2401184ĐKLH/BYT-HTTB and manufactured by SolGent Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN GIẢI PHÁP Y TẾ VÀ KHOA HỌC SURAN.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including SD Biosensor Inc., Bioneer Corporation, and 2 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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