Access Bio Approves FDA For Simultaneous Self-Diagnosis Kit Of COVID-19 And Flu
Aug 26, 2025
Access Bio announced on the 22nd that it has obtained 510(k) approval from the US Food and Drug Administration (FDA) for a combo self-diagnosis kit 'CareSuperb COVID-19/Flu A&B Antigen Combo Home Test' that can diagnose COVID-19 and flu at the same time.
This product is the second product developed based on its worry-sensitive platform CareSuperb technology, and is the follow-up to the COVID-19 single diagnostic kit introduced earlier.
'CareSuperb COVID-19/Flu A&B Antigen Combo Home Test' can diagnose COVID-19 and influenza A and B types simultaneously within 10 minutes. In particular, the two patients have similar symptoms in winter, so it is important to accurately discriminate when choosing a treatment, and this product can enable rapid and efficient diagnosis, the company explained.
The company will supply in partnership with partners with large North American retail networks such as CVS, Walgreens and Target in line with the 2025-2026 winter respiratory disease epidemic season. At the same time, it plans to actively enter the public procurement market and diversify its sales channels. In particular, the entire process from development to production and delivery is carried out in the United States, which is expected to secure a competitive advantage amid the strengthened Buy American Act and the imposition of tariffs on overseas manufactured products.
"We will actively expand our growth opportunities based on our production capacity and global network in the United States amid the strengthening of the Buy American Act," an Access Bio official said.
This product is the second product developed based on its worry-sensitive platform CareSuperb technology, and is the follow-up to the COVID-19 single diagnostic kit introduced earlier.
'CareSuperb COVID-19/Flu A&B Antigen Combo Home Test' can diagnose COVID-19 and influenza A and B types simultaneously within 10 minutes. In particular, the two patients have similar symptoms in winter, so it is important to accurately discriminate when choosing a treatment, and this product can enable rapid and efficient diagnosis, the company explained.
The company will supply in partnership with partners with large North American retail networks such as CVS, Walgreens and Target in line with the 2025-2026 winter respiratory disease epidemic season. At the same time, it plans to actively enter the public procurement market and diversify its sales channels. In particular, the entire process from development to production and delivery is carried out in the United States, which is expected to secure a competitive advantage amid the strengthened Buy American Act and the imposition of tariffs on overseas manufactured products.
"We will actively expand our growth opportunities based on our production capacity and global network in the United States amid the strengthening of the Buy American Act," an Access Bio official said.
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This article was translated by Naver AI translator.
