Zybio's SARS-CoV-2 IgM/IgG Antibody Assay Kit obtained EU CE certification

March 28,2020 Zybio News

CE marked product

SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)


• Quick to result in 10 minutes

• Suitable for different blood sample types

• Easy to operate, only 3 steps needed

 No instruments and additional consumables

 Easy for long-distance transportation


This is the second time that Zybio has obtained the EU CE certification this month. Previously, on March 9th, Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) and Nucleic Acid Extraction Kit (Magnetic Bead Method) have successfully obtained the EU CE certification.

"CE" is read as an abbreviation of "conformité européenne". In the EU market, the "CE" mark is a compulsory certification mark. After the product complies with the requirements of the EU Medical Device Directive, the product can be freely circulated in the EU market. At present, these products have been registered with the competent authorities of the European Union and have the access conditions for the European Union market.


The COVID-19 pandemic situation in China has gradually stabilized, but the international pandemic situation has become increasingly severe. Over the years, Zybio has been deeply involved in the international market and has reached in-depth cooperation with customers in more than 40 countries. We will keep concerning about the development trend of the global pandemic, uphold the serve for humnan health, take the responsibility of fighting the epidemic, and do our best to meet the needs of the epidemic area.