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Qualitative RNA Test for SARS-CoV-2 - Vietnam Registration 2401184ĐKLH/BYT-HTTB

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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2401184ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2401184ĐKLH/BYT-HTTB
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Device Details

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
Risk Class TTBYT Loại C

Registration Details

2401184ĐKLH/BYT-HTTB

000.00.04.G18-220908-0001

DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit

SQD52-K100

Company Information

REPUBLIC OF

SolGent Co., Ltd.

Technical Details

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

Jul 22, 2024

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