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Good news,Lumigenex won the EU CE1434 certificate!

  • Categories:Company News
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  • Time of issue:2022-04-30 10:12
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(Summary description)PocRoc® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) for self-test independently developed by Lumigenex won the EU CE1434 certificate!

Good news,Lumigenex won the EU CE1434 certificate!

(Summary description)PocRoc® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) for self-test independently developed by Lumigenex won the EU CE1434 certificate!

  • Categories:Company News
  • Author:
  • Origin:
  • Time of issue:2022-04-30 10:12
  • Views:
Information

On April 29, 2022, PocRoc® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) for self-test independently developed by Lumigenex won the EU CE1434 certificate! This means that the self-test product can be sold in 27 EU Member States and other countries that recognize EU CE1434 certificate, and the consumers can buy it in the supermarkets or pharmacies.

The EU CE1434 certificate is different from the CE Declaration of Conformity. It needs to be subject to the strict technical review of the manufacturer's medical device products by the Noted Body recognized by the EU. At the same time, it needs to pass the clinical trial to prove that the product is safe and reliable in clinical performance and meets the international technical requirements before it can be issued. This time, Lumigenex obtained the EU CE1434 certificate, which once again proves that the self-test products developed and produced by Lumigenex are reliable in quality and accurate in results!

PocRoc® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) for self-test is easy to be used by layusers by collecting nasal swabs, and the results can be obtained in 15 minutes. It is convenient for layusers to carry out rapid detection of novel coronavirus, and can better meet the needs of epidemic prevention and control in the European Union

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