Guangzhou Wondfo Biotech's American subsidiary has obtained FDA 510(k) clearance for its respiratory tract triplex test product.

Guangzhou Wondfo Biotech (300482.SZ) announced that its wholly-owned subsidiary in the United States, Wondfo USA Co., Ltd (referred to as "US subsidiary"), recently received a notification from the U.S. Food & Drug Administration (FDA) that the new coronavirus, influenza A, and influenza B three-in-one family test kits (OTC version) WELLlife COVID-19 / Influenza A&B Home Test and the new coronavirus, influenza A, and influenza B three-in-one test kit (Professional use version) WELLlife COVID-19 / Influenza A&B Antigen Test have obtained FDA 510(k) clearance.