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

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

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

CLIAwaived.com is Authorized supplier of all WELL LIFE Products/ Partner with CLIAwaived.com for all WELL LIFE Products

Contact us today at:  [email protected] to learn more about the WELLlife™ test and how it can enhance your diagnostic capabilities. 

 

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