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Osang Healthcare receives US FDA emergency use authorization for personal COVID-19 and influenza combo kit

Apr 4, 2024

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Following approval for professional use, personal use products also approved

On the 4th, Osang Healthcare (036220), a company specializing in in vitro diagnostics (IVD), announced that it had received Emergency Use Authorization (EUA) from the US FDA for its personal use COVID-19 and influenza combo kit.

The COVID-19 and influenza combo kit that Osang Healthcare received FDA emergency use authorization for is a diagnostic device that can simultaneously detect COVID-19 and influenza A and B. This comes about two weeks after the company received approval for its professional-use product on the 22nd of last month, making it the second personal rapid test product in the world and the first from a domestic company to receive approval.

 

 

 

Full article : Osang Healthcare receives US FDA emergency use authorization for personal COVID-19 and influenza combo kit