FilingReader Intelligence
Wondfo Biotech's US unit gains FDA clearance for flu tests
August 21, 2025 at 07:59 AM UTC•By 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
SZSE:300482•Shenzhen Stock Exchange
News Alerts
Get instant email alerts when Guangzhou Wondfo Biotech publishes news
Free account required • Unsubscribe anytime