▲ This imaged, provided by South Korean biopharmaceutical company Celltrion Inc. on Oct. 25, 2021, shows its DiaTrust COVID-19 Ag Home Test. (PHOTO NOT FOR SALE) (Yonhap)

Celltrion-coronavirus kit

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

By Kim Han-joo

SEOUL, Oct. 25 (Yonhap) -- South Korean biopharmaceutical company Celltrion Inc. said Monday that its self-diagnostic kit for the novel coronavirus has won emergency approval from U.S. drug authorities.

Celltrion DiaTrust COVID-19 Ag Home Test, co-developed by local healthcare business Humasis, received the U.S. 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.

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