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Home / News / Company News / An Overview of SARS-CoV-2 Antigen Kit Certification Received by Goldsite (In Update)

An Overview of SARS-CoV-2 Antigen Kit Certification Received by Goldsite (In Update)

Publish Time: 2021-09-01     Origin: Site


Certification/ List Country/ Region Issued Institution

EC Certificate for self-testing

European Union (EU)
EU Common List European Union (EU)



European Commission

Pass Phase 3 Evaluation
United Kingdom

List of Antigen tests for direct pathogen detection of the coronavirus SARS-CoV-2

Germany
Pass PEI Evaluation Germany

ANSM authorization for SARS-CoV-2 Antigen Kit for Self-testing

France



Authorization Italy

Ministry of Health(MOH)

List of recommended tests Belgium
Authorization Swiss
Authorized New Zealand

Authorization

for self-testing

Spain

Ministry of Health(MOH)

Authorization Hong Kong
Authorization Macao
Authorization Slovakia
Authorization Bosnia and Herzegovina
Authorization Romania
Malaysia MDA Authorization Malaysia

Thailand FDA authorization

Self test

Thailand
Emergency Use Authorization (EUA)

Bangladesh 

Saudi Food and Drug Authority (SFDA) Authorization Saudi Arabia




Goldsite Diagnostics Inc., founded in 1999, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents.

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