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South Korea's Covid self-test kit gets FDA emergency approval

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Seoul, Oct 25 (IANS) South Korean biopharmaceutical company Celltrion announced on Monday that its self-diagnostic kit for Covid-19 has been granted 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 authorisation approval, according to a company statement, Yonhap News Agency reported.

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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.

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

The self-test kit has also been granted approval for emergency use by other countries, including South Korea.

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It is also used in several European countries,the report said.

–IANS

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