Product Overview
The WELLlife™ COVID-19 / Influenza A&B Antigen Test is a rapid lateral flow assay for the qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B antigens from anterior nasal swab specimens. Designed for professional point-of-care use, the test provides results in approximately 10 minutes and is CLIA waived. The WCOVFLU-POC-25 configuration contains 25 tests per kit, making it suitable for clinics, laboratories, urgent care centers, hospitals, and other qualified healthcare settings. The test was cleared by the FDA under 510(k) K243256 and allows COVID-19 and influenza A/B testing from a single collected specimen.
Product Features
- Detects SARS-CoV-2, Influenza A, and Influenza B antigens
- Differentiates COVID-19, Influenza A, and Influenza B results
- Uses anterior nasal swab specimens
- Provides results in approximately 10 minutes
- CLIA waived for eligible professional testing environments
- FDA 510(k) cleared under K243256
- Convenient rapid test cassette format
- Single-specimen testing for three respiratory viral targets
- Intended for professional use in laboratories, clinics, urgent care centers, and hospitals
- Packaged 25 tests per kit
Product Specifications
| SKU/Catalog Number | MF-WCOVFLU-POC-25 |
| Product Type | COVID-19 & Influenza A/B Rapid Antigen Test |
| Product Name | WELLlife™ COVID-19 / Influenza A&B Antigen Test |
| Brand | WELLlife™ |
| Manufacturer | Wondfo USA Co., Ltd. |
| Manufacturer Part Number | WCOVFLU-POC-25 |
| Test Format | Cassette |
| Test Method | Rapid Lateral Flow Antigen Assay |
| Detection Target | SARS-CoV-2, Influenza A, and Influenza B Antigens |
| Specimen Type | Anterior Nasal Swab |
| Result Type | Qualitative |
| Test Time | Approximately 10 Minutes |
| CLIA Classification | Waived |
| FDA Status | 510(k) Cleared |
| FDA 510(k) Number | K243256 |
| Packaging | Box/25 Tests |
| Quantity per Box | 25 Tests |
| Application | Point-of-Care COVID-19 and Influenza A/B Testing |
| Intended Use | Professional In Vitro Diagnostic Use |