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Celltrion's coronavirus self-test kit gets FDA emergency approval

By Yonhap

Published : Oct. 25, 2021 - 10:37

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This imaged, provided by South Korean biopharmaceutical company Celltrion Inc. on Monday, 2021, shows its DiaTrust COVID-19 Ag Home Test. (Celltrion Inc.) This imaged, provided by South Korean biopharmaceutical company Celltrion Inc. on Monday, 2021, shows its DiaTrust COVID-19 Ag Home Test. (Celltrion Inc.)
South Korean biopharmaceutical company Celltrion Inc. said Monday that its self-diagnostic kit for the novel coronavirus has won emergency approval from US drug authorities.

Celltrion DiaTrust COVID-19 Ag Home Test, co-developed by local healthcare business Humasis, received the US Food and Drug Administration's Emergency Use Authorization approval.

The product uses an antibody that specifically binds to the COVID-19 virus and detects infection within 15 minutes, Celltrion said. It is most suitable for identifying acute or early infection of the COVID-19 virus.

Celltrion USA, which handles Celltrion's overseas business, will be responsible for the sales. 

The self-test kit has also won approval for emergency use by other countries, including South Korea. It is also used in several European countries. (Yonhap)

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