Wondfo’s WELLlife™ 510(k) Cleared COVID Flu A&B Test launched
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.
Partner with Wondfo for Reliable Diagnostics
With the WELLlife™ Flu A&B Test, Wondfo continues to support global efforts in combating respiratory illnesses. Our dedication to innovation and quality ensures that you have the tools needed to make informed decisions and protect public health.
Contact us today to learn more about the WELLlife™ test and how it can enhance your diagnostic capabilities. Together, we can make a difference.
