Wondfo’s WELLlife™ 510(k) Cleared COVID Flu A&B Test launched

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We are proud to announce that Wondfo’s WELLlife™ Flu A&B Test for both OTC (Home) and Professional use has officially received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This milestone represents a significant advancement in our mission to support healthcare providers and consumers with timely and accurate diagnostic testing solutions.

About the WELLlife™ Flu A&B Test

The test distinguishes between Influenza A, and Influenza B with a single nasal swab, providing rapid and accurate results in just 10 minutes. This makes it an essential tool for maintaining a safe and healthy environment.

Key Features of the Test

Dual Detection
- Differentiates between Influenza A, and Influenza B, providing a clear diagnosis.
Fast Results
- Provides reliable results in a matter of minutes, enabling prompt decision-making.
High Sensitivity and Specificity
- Meets rigorous standards for accuracy, ensuring trust in every test result.
User-Friendly Design
- Easy to use, making it suitable for point-of-care settings, healthcare professionals and home (OTC) use.
Suitable for All Ages
- Can be used independently by individuals 14 years and older. Adult collection required for individuals 2-13 years.

Why 510(k) Clearance Matters

510(k) clearance is granted to products that meet stringent safety, performance, and reliability criteria. With this clearance, the WELL life™ test is recognized as a trusted tool in respiratory illness diagnosis.

How the WELL life™ Test Supports Public Health

Streamlines Diagnosis
- Rapid identification of flu is necessary for appropriate treatment and containment strategies.
Reduces Strain on Healthcare Systems
- Quick and accurate results help minimize unnecessary testing and allow healthcare providers to prioritize resources effectively.
Empowers Healthcare Professionals
- Provides actionable insights, ensuring patients receive timely and targeted care.