FilingReader Intelligence

Wondfo Biotech's US unit gains FDA clearance for flu tests

August 21, 2025 at 07:59 AM UTCBy FilingReader AI

Wondfo USA obtained FDA 510(k) clearance for its WELLlife Flu A&B Home Test and professional-use version. Both products detect and differentiate influenza A and B viruses from nasal samples within four days of symptom onset.

The home test is the first of its kind to receive FDA approval in the US.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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