Qualitative Test for SARS-CoV-2 Antigen - Vietnam Registration 2403547ĐKLH/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 TBYT Loại C medical device is registered under number 2403547ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.

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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2403547ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403547ĐKLH/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 TBYT Loại C

Registration Details

Analysis ID

2403547ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-231117-0009

Product Type

STANDARD™ Q COVID-19 Ag Home Test

Product Code

Theo phụ lục

Technical Details

Intended Use

STANDARD™ Q COVID-19 Ag Home Test is a qualitative flow-through lateral flow test for the detection of nucleocapsid antigen in human nasal swab samples. The test is used to detect the antigens of SARS-CoV-2 in individuals suspected of being infected with COVID-19. The product is designed for self-testing by patients.