Access Bio Subsidiary Wells Bio Obtains MFDS Export Approval for COVID-19 Antigen Rapid Test Kit
Full-Scale Export and Sales of COVID-19 Antigen Rapid Test Kits Begin
[Asia Economy Reporter Koo Eun-mo] Access Bio, a company specializing in in vitro diagnostics, announced on the 6th that its subsidiary Wells Bio has obtained export approval from the Ministry of Food and Drug Safety (MFDS) for its COVID-19 antigen rapid diagnostic kit.
Access Bio's subsidiary Wells Bio received export approval from the MFDS on the 5th for the COVID-19 antigen rapid diagnostic kit (careUS™ COVID-19 antigen), officially starting the export sales of the COVID-19 antigen diagnostic kit.
Wells Bio's COVID-19 antigen rapid diagnostic kit, careUS™ COVID-19 antigen, collects patient specimens from the nasopharynx and nasal cavity and uses an immunochromatography method to quickly diagnose infection status within 10 to 15 minutes.
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Wells Bio holds European certification for two product lines: COVID-19 antibody diagnostic kits and molecular diagnostic kits, and plans to apply for European certification for the antigen rapid diagnostic kit in the near future.
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