Description
WellLife Covid Flu Package Insert
WellLife Covid Flu Quick Guide
WELLlife-COVID-19-Influenza-AB-Test-FAQs
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories.
Contents: Each box contains: Test Devices (2), Tubes (2), Nasal swabs (2), Holder (1), Quick Reference Instructions (QRI) (1)
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen, Influenza A&B
Storage Requirements: 36-86°F (2-30°C)
Processing Time: 10 Minutes
The Wondfo Clarity WELLlife™ COVID-19 / Influenza A&B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals aged two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
Features and Benefits
- Comprehensive Detection: Simultaneously tests for COVID-19 and Influenza A & B.
- Fast Results: Get reliable and accurate results in just 10 minutes.
- Home Convenience: Perform the test at home, avoiding doctor visits and crowded clinics.
- User-Friendly: Simple instructions ensure easy and accurate use.
- FDA EUA Authorized: Meets all OTC requirements for safe and efficient standards for at-home testing.
- Extended Detection Window: Offers a broader detection window for differentiation of SARS-COV-2, influenza A, and influenza B antigens within five (5) days of symptom onset.
- Pre-loaded 12-Pack Retail Holder Design: Retail holders come pre-loaded with a total of 12 OTC 1/2ct packs for a total of 12/24 tests. Convenient for retail and pharmacy countertop displays or storage. Features a header card display with QR code for further product details and instructions.
See product links above for additional information or contact your local Stat Technologies sales representative
