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Wondfo COVID-19/Influenza A&B Test Kit Receives FDA EUA
April 23,2024 (Edit) Wondfo
Recently, Wondfo Biotech's wholly-owned subsidiary in the United States, Wondfo USA Co., Ltd. (hereinafter referred to as the " Wondfo USA"), received notification from the U.S. Food and Drug Administration (FDA) that the WELLlife™ COVID-19/Influenza A&B Test has been granted Emergency Use Authorization (EUA240004). The WELLlife™ COVID-19/Influenza A&B Test is designed for professional use at the point-of-care (POC) settings.
Respiratory virus infections caused by influenza A, influenza B, or the SARS-COV-2 viruses exhibit similar clinical manifestations. To differentiate respiratory infections caused by different viruses and provide targeted treatment, there is a need for a product capable of detecting and distinguishing different pathogenic viruses. In response to the high prevalence of seasonal respiratory infectious diseases in the United States, the FDA has opened an Emergency Use Authorization (EUA) pathway. Wondfo USA's WELLlife™ COVID-19/Influenza A&B Test has successfully completed performance and clinical validation in the United States and has obtained FDA EUA. The product can qualitatively detect and differentiate between influenza A, influenza B, and the SARS-COV-2 infections in anterior nasal samples within 5 days of symptom onset.
The FDA EUA for the above-mentioned product further enriches the company's product portfolio, enhances its core competitiveness, and has a positive impact on the company's development in the U.S. market.
From HIV, SARS, influenza A and B, H7N9 to COVID-19, Wondfo has always been actively involved in global public health emergency responses, using technology to support epidemic prevention and control. Wondfo will continue to promote scientific research innovation to global health services.
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