Beijing UniDiag’s SARS-CoV-2 Antigen Rapid Test Kit Won NB CE Self-test Certificate

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       UniDiag is pleased to announce that our SARS-CoV-2 Antigen Rapid Test (colloidal gold  method) has successfully obtained the EU CE certificate for self-test. CE Self-test approved by a four-digit numbered notified body is the highest level CE certification for rapid antigen tests. Manufacturer are required of not only a conforming quality management system, but also performance test and usability study completed at a third-party clinical institution in the EU. The evaluation standard is strict and the evaluation process is objective. This Certification indicates that UniDiag’s excellent rapid antigen test kit is now good to be marketed across all EU member countries as well as those countries that recognize CE certification.

       UniDiag’s SARS-CoV2 Antigen Rapid Test (colloidal gold method) is designed based on colloidal gold immunochromatography. Without the need of any supporting device, individuals can easily collect samples from anterior nasal swabs and read the the detection result in about just 15 minutes. Our product features high sensitivity and specificity, fast color development, stable performance and high cost performance.

       The professional use version of the product has been registered in countries such as MOH of Spain and BfArM of Germany. UniDiag is also proactively proceeding with registrations in countries such as CTDA of the UK, TGA of Australia, New Zealand and Canada, etc. At present, the company is fast-tracking on the development of overseas market for the antigen rapid test product line and we’d welcome distributors and trade partners from all countries and regions across Europe, ASEAN, Middle East and Latin America.  


2022年5月10日 18:11