WELLlife™
WELLlife COVID-19/Flu A&B Home Test is a cassette-based antigen test for detecting and differentiating SARS-CoV-2, influenza A and influenza B antigens in anterior nasal swab specimens. The…
WELLlife COVID-19/Flu A&B Home Test is a cassette-based antigen test for detecting and differentiating SARS-CoV-2, influenza A and influenza B antigens in anterior nasal swab specimens. The filed package contains two tests and a holder.
The test uses a lateral-flow immunoassay format with target-result regions and a control region on its cassette.
Listed Item
WELLlife™ COVID-19/Flu A&B Home Test Cassette, New Package 2 Tests per Kitbox with Holder
Test Cassette and Package
The lateral-flow cassette displays target-specific result regions and a control region after the specimen is processed. The holder supports the sample tube as part of the two-test home package.
The test is intended to detect and differentiate SARS-CoV-2, influenza A and influenza B antigens in anterior nasal swab specimens. Its two-test package is one defined home-test configuration.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Biohit Healthcare (Hefei) Co., Ltd. | Hefei | Anhui | Contract manufacturer | 4 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
Record
| Listed by | Wondfo USA Co., Ltd., United States |
|---|---|
| FDA product code | SCA |
| Device type | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3987 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2025-05-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 30 °C |
| Packaging | Pack of 18, pack of 54, pack of 144, pack of 72, pack of 33, pack of 216 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WCOVFLU-POC-25 | 25 | In distribution | |
| WFLUAB-OTC-N1 | In distribution | ||
| WCOVFLU-OTC-N2 | 2 | In distribution | |
| WCOVFLU-OTC-10 | 10 | In distribution | |
| WCOVFLU-OTC-N25 | 25 | In distribution | |
| WCOVFLU-POC-10 | 10 | In distribution | |
| WCOVFLU-OTC-2 | 2 | In distribution | |
| WCOVFLU-OTC-N10 | 10 | In distribution | |
| WCOVFLU-POC-25S | 25 | In distribution | |
| WCOVFLU-OTC-5 | 5 | In distribution | |
| WCOVFLU-POC-5 | 5 | In distribution | |
| WCOVFLU-OTC-N5 | 5 | In distribution | |
| WFLUAB-OTC-10 | 10 | In distribution | |
| WCOVFLU-OTC-2S | 2 | In distribution | |
| WCOVFLU-OTC-N1 | In distribution | ||
| WFLUAB-OTC-N25 | 25 | In distribution | |
| WFLUAB-OTC-25 | 25 | In distribution | |
| WFLUAB-OTC-N2 | 2 | In distribution | |
| WFLUAB-OTC-N5 | 5 | In distribution | |
| WCOVFLU-OTC-1 | In distribution | ||
| WFLUAB-OTC-N10 | 10 | In distribution | |
| WCOVFLU-OTC-25 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BinaxNOW COVID-19/Flu A&B Combo Self Test | Alere Scarborough, Inc. | 12 |
| iHealth | iHealth Labs, Inc. | 7 |
| QuickFinder™ COVID-19/Flu Antigen Self Test | Osang Healthcare Co., Ltd. | 4 |
| Rapid Response | Btnx Inc. | 3 |
| Healgen | Healgen Scientific Limited Liability Company | 3 |
| HealthConfirm | Confirm Biosciences LLC | 3 |
| CareSuperb COVID-19/FluA&B Antigen Combo HomeTest | Access Bio, Inc. | 3 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 2 |
| COVID/Flu A&B RespiraDXTM Rapid Self-Test | Inbios International, Inc. | 2 |
| GenaCheck® COVID-19/Flu A&B Rapid Self-Test | Genabio Diagnostics Inc | 2 |
| Walgreens | Walgreen Co. | 2 |
Showing 12 of 28. All products under Multi-Analyte Respiratory Virus Antigen Detection Test
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251563 | 2025-08-20 |
| K243256 | 2025-01-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.