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BioWorld - Wednesday, May 20, 2026
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Home » Celltrion wins EUA for latest COVID-19 test kit
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Celltrion wins EUA for latest COVID-19 test kit

Oct. 26, 2021
By Gina Lee
Celltrion Inc. recently received FDA emergency use authorization (EUA) for its Diatrust COVID-19 Ag home test. “With the FDA approval, we will now prioritize getting the test kits to the U.S. and into users’ hands as soon as possible,” a spokesperson for the Incheon, South Korea-based Celltrion told BioWorld. The test kits will be distributed through Celltrion’s U.S. arm, Celltrion USA Inc. Celltrion is currently in the final stage of negotiations with the U.S. government, as well as online and offline distributors.
Medical technology Regulatory Diagnostics Coronavirus FDA

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