 Tel:+86-755-26890807
Email: sales@goldsite.com.cn
News Detail
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)

Author: Site Editor     Publish Time: 2021-09-01      Origin: Site


Certification/ List Country/ Region Issued Institution

EC Certificate for self-testing

European Union (EU) Self-test Covid-19 antigen detection kit Sichuan Yinye Medical Technology Co Ltd.
EU Common List European Union (EU)


European Commission logo


European Commission

Pass Phase 3 Evaluation
United Kingdom Department of Health & Social Care(DHSC)

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

Germany
Pass PEI Evaluation Germany Logo: Paul Ehrlich Institute: Federal Institute for Vaccines and Biomedical Drugs (link to homepage)

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

France


Ministry of Solidarity and Health


ANSM

Authorization Italy

Ministero della Salute

Ministry of Health(MOH)

List of recommended tests Belgium Back to the home page
Authorization Swiss Federal Office of Public Health
Authorized New Zealand

Authorization

for self-testing

Spain

Gobierno de EspañaMinisterio de Sanidad

Ministry of Health(MOH)

Authorization Hong Kong
Authorization Macao
Authorization Slovakia Úrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky
Authorization Bosnia and Herzegovina
Authorization Romania National Agency for Medicines and Medical Devices of Romania
Malaysia MDA Authorization Malaysia header en

Thailand FDA authorization

Self test

Thailand
Emergency Use Authorization (EUA)

Bangladesh 

Directorate General of Drug Administration (DGDA)
Saudi Food and Drug Authority (SFDA) Authorization Saudi Arabia



white list map


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

Quick Links

Product Links

Get in touch

    (+86)-755-26890807

        (+86)-755-26897973
   sales@goldsite.com.cn

 

Copyright ©  2021 Goldsite Diagnostics Inc., All rights reserved.  Sitemap