Medical Technologies
TE Connectivity Plays Important Role in the FDA Clearance of Wondfo’s Over-the-Counter COVID-19 Antigen Test
Congratulations to Wondfo USA (“Wondfo”) for receiving FDA 510(k) clearance for its WELLlife 2019-nCoV antigen test for over-the-counter (OTC) use with assistance from TE Connectivity’s IVD Solutions team. This marks a significant milestone in the fight against COVID-19, providing individuals with a fully cleared, over-the-counter test for ages 14 years and older through self-collection and ages 2 years and older with adult-collection.
Wondfo OTC COVID-19 Antigen Test FDA 510(K) Cleared
The Wondfo WELLlife COVID-19 antigen test offers rapid results in 10 minutes, making it convenient for home use. This test is designed to help individuals quickly assess their COVID-19 status so the users can take appropriate steps to protect themselves and others.
“We are proud to have played an important role in helping Wondfo achieve 510(k) clearance for their OTC COVID-19 test,” said Uwe Winzen, general manager - microfluidics at TE Connectivity. “Our extensive expertise in IVD clinical studies, particularly for respiratory devices, has been instrumental in ensuring that Wondfo was able to obtain clearance for the U.S. market.”
TE Connectivity has significant experience collaborating with innovative companies like Wondfo to bring their diagnostic solutions to market quickly and successfully. By leveraging its deep understanding of FDA expectations and its proven track record of successful clinical studies, TE Connectivity has helped Wondfo accelerate the development and regulatory approval of their COVID-19 test.
"We are thrilled to collaborate with TE Connectivity to introduce the WELLlife COVID-19 home test to the US market. Wondfo specializes in manufacturing and distributing rapid point-of-care products. The FDA 510(k) clearance for the WELLlife COVID-19 home test demonstrates Wondfo’s commitment to the OTC infectious disease market," said Jimmy Chen, general manager at Wondfo.
The WELLlife COVID-19 antigen test is expected to be available for purchase in the United States in the Fall of 2024.
Learn more about collaborating with the TE Connectivity IVD Solutions team for CRO services on your device here or contact one of our CRO specialist here.
Learn more about Wondfo USA by visiting their website here..
