Vietnam MOH registration 2400626ĐKLH/BYT-HTTB

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
Vietnam flagVietnam·Risk Class TTBYT Loại C·Allplex™ GI-Virus plus Assay·Seegene, Inc.·Registered May 10, 2024
Registration details
Analysis ID
2400626ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-200820-0005
Product Type
Allplex™ GI-Virus plus Assay
Product Code
GI10188X
Company information
Manufacturer
Seegene, Inc.
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
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
Registration Date
May 10, 2024
About this record

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.

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