QuickFinder™ COVID-19/Flu Antigen Self Test
The QuickFinder COVID-19/Flu Antigen Self Test detects and differentiates SARS-CoV-2, influenza A and influenza B antigens in an anterior nasal swab. It is a rapid lateral flow test for…
The QuickFinder COVID-19/Flu Antigen Self Test detects and differentiates SARS-CoV-2, influenza A and influenza B antigens in an anterior nasal swab. It is a rapid lateral flow test for people with symptoms of respiratory infection.
Antibodies capture the target antigens as the sample moves through the cassette, producing visible lines at separate result positions. A control line indicates that the test has functioned as intended.
Listed Item
1 Test Kit / Box
Users and Results
The test supports self-testing from age 14, or adult collection for children aged 2 and older. Samples are tested directly without transport medium. Negative results are presumptive and do not exclude infection; continued or worsening symptoms require healthcare follow-up.
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 | Osang Healthcare Co., Ltd., South Korea |
|---|---|
| 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K243262 |
| Record published | 2025-03-17 |
| Record revised | 2025-03-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 36 to 86 °F; Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OI-01SU-CC | In distribution | |
| OI-01SU-CC | In distribution | |
| OI-01SU-CC | In distribution | |
| OI-01SU-CC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| WELLlife™ | Wondfo USA Co., Ltd. | 22 |
| BinaxNOW COVID-19/Flu A&B Combo Self Test | Alere Scarborough, Inc. | 12 |
| iHealth | iHealth Labs, Inc. | 7 |
| 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 |
|---|---|
| K243262 | 2025-01-13 |
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.