AccessBio Completes European Certification for COVID-19 Antigen Rapid Test Kit

[Asia Economy Reporter Eunmo Koo] Access Bio announced on the 23rd that it has completed the European certification (CE) for its novel coronavirus (COVID-19) antigen rapid diagnostic kit.

This registration can be verified through the German Federal Institute for Drugs and Medical Devices (BfArM) website. A company official explained, “Although we have not yet received the official certificate, in this case, the registration was first confirmed via the German BfArM website, and for European countries, diagnostic products registered in one country are also permitted in other European Union member states.”

Through this registration, Access Bio will be qualified to sell COVID-19 antigen diagnostic kits throughout Europe.

The CareStart COVID-19 Antigen rapid diagnostic kit collects specimens from the patient’s nasopharynx and uses immunochromatography to quickly diagnose COVID-19 infection within 10 to 15 minutes.

Access Bio currently holds European certification for a total of three product lines: COVID-19 antigen diagnostic kits, antibody diagnostic kits, and molecular diagnostic kits.