Access Bio Receives FDA Clearance for 'COVID-19/Flu Combo Self-Test Kit'
by Choi Taewon
Published 25 Aug.2025 10:10(KST)
Targeting the U.S. Retail Market
Expanding Supply Channels with Domestic Production and Regulatory Approval
Access Bio announced on the 25th that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its combo self-test kit, the 'CareSuperb COVID-19/Flu A&B Antigen Combo Home Test,' which can simultaneously diagnose COVID-19 and influenza.
The 'CareSuperb COVID-19/Flu A&B Antigen Combo Home Test' is known to be able to simultaneously and distinctly diagnose COVID-19 and influenza A and B within 10 minutes.
Access Bio plans to supply the product in partnership with companies possessing large retail networks in North America, targeting the 2025-2026 winter respiratory disease season. At the same time, the company will actively enter the public procurement market to diversify its sales channels. In particular, since all processes from development and production to delivery are carried out within the United States, Access Bio expects to secure a competitive advantage amid the strengthened Buy American Act and the trend of imposing tariffs on foreign-made products.
An Access Bio representative stated, "Amid the strengthened Buy American Act, we will actively expand growth opportunities based on our production capabilities in the United States and our global network."
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