On Apr. 30, 2020, Medigen Vaccine Biologics (MVB) received notice that its SARS-CoV-2 qPCR Kit had complied with EU CE requirement. MVB has completed the EU declaration of conformity and obtained CE marking (IVD).

This qPCR Kit can directly test upper/lower respiratory tract specimens which reduce laboratoriesﾒ extra preparation time and manpower. It is limited to the use of domestic laboratories accredited by Taiwan CDC during the approved manufacturing period until the dissolution of the Central Epidemic Command Center.