Qualitative Test for SARS-CoV-2 Antigen - Vietnam Registration 2301335ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative Test for SARS-CoV-2 Antigen in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2301335ĐKLH/BYT-HTTB and manufactured by CERTEST BIOTEC, S.L..

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including Abbott Rapid Dx Galway, GeneSign Biotech (Xiamen) Co., Ltd, and 5 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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2301335ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2301335ĐKLH/BYT-HTTB

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Device Details

Qualitative Test for SARS-CoV-2 Antigen

VN: Khay thử xét nghiệm định tính kháng nguyên SARS-CoV-2

Risk Class TTBYT Loại D

Registration Details

Analysis ID

2301335ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-201228-0019

Product Type

CerTest SARS-CoV-2

Product Code

SC820001PC

Technical Details

Intended Use

The Certest SARS-CoV-2 One-Step Test is an immuno-chromatographic colorimetric qualitative test for the detection of the nucleoprotein antigen of SARS-CoV-2 in nasopharyngeal or nasal swab samples from suspected COVID-19 patients. The Certest SARS-CoV-2 Test is a simple screening test aimed at supporting the diagnosis of SARS-CoV-2 infection.