[Featured Stock] Suzentec Hits Upper Limit Following FDA Approval of COVID-19 Rapid Test Kit

[Asia Economy Reporter Ji Yeon-jin] Diagnostic kit company SuzenTec is hitting the upper limit in the KOSDAQ market on the 26th after receiving Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid test kit.

SuzenTec started trading with a slight decline in the morning but surged 29.95% compared to the previous session from around 9:31 AM.

On this day, SuzenTec announced that it succeeded in obtaining CLIA-waived FDA Emergency Use Authorization (EUA) for the "COVID-19 antibody rapid test kit using fingertip blood," which can be applied for on-site diagnostics. CLIA-waived products can be used for diagnosis in small hospitals and pharmacies, allowing the product to be supplied through a wide range of distribution channels.

The CLIA-waived antibody diagnostic EUA product for on-site testing using fingertip blood must pass very stringent clinical requirements demanded by the U.S. FDA, and so far, only five companies worldwide have received approval. SuzenTec achieved the distinction of being the first domestic company and the sixth globally to receive CLIA-waived FDA approval.

This content was produced with the assistance of AI translation services.