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Qualitative DNA Adenovirus and RNA Norovirus GI, Norovirus GII, Rotavirus A, Astrovirus and Sapovirus Test Kit - Vietnam Registration 2400626ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative DNA Adenovirus and RNA Norovirus GI, Norovirus GII, Rotavirus A, Astrovirus and Sapovirus Test Kit 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 2400626ĐKLH/BYT-HTTB and manufactured by Seegene, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

This page provides complete technical specifications, regulatory compliance details. 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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2400626ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2400626ĐKLH/BYT-HTTB
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Device Details

Qualitative DNA Adenovirus and RNA Norovirus GI, Norovirus GII, Rotavirus A, Astrovirus and Sapovirus Test Kit
VN: Bộ xét nghiệm định tính ADN Adenovirus và ARN Norovirus GI, Norovirus GII, Rotavirus A, Astrovirus và Sapovirus
Risk Class TTBYT Loại C

Registration Details

2400626ĐKLH/BYT-HTTB

000.00.04.G18-200820-0005

Allplex™ GI-Virus plus Assay

GI10188X

Company Information

REPUBLIC OF

Technical Details

Qualitative in vitro testing to detect single or multiple Norovirus GI (NVG1), Norovirus GII (NVG2), Rotavirus A (ROV), Adenovirus (ADV; Species A, B, C, D, E, F and G), Astrovirus (ASV) and Sapovirus (SV; Genogroup G1, 2, 4, 5) Astrovirus and Sapovirus in samples from individuals with symptoms of gastroenteritis or infectious diarrhea.

Dates and Status

May 10, 2024