Osang Healthcare receives US FDA 510(k) clearance for COVID-19/influenza combo kit

▶ Formal approval 10 months after receiving emergency use authorization (EUA) from the US FDA in March last year

▶ 510(k) approval for a combo rapid test product for personal and professional use...

▶ Global company contract completed... Full production to begin in January

The COVID-19/influenza combo kit recently approved by the FDA is a diagnostic device that can simultaneously detect COVID-19 and influenza A and B. It received emergency use authorization in March and has been approved after approximately 10 months. It is the world's first 510(k) approval for a personal/professional combo rapid test product.

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연합뉴스 : https://www.yna.co.kr/view/AKR20250114136100017?input=1195m

한국경제 : https://www.hankyung.com/article/2025011459041