QuickFinder™ COVID-19/Flu Antigen ProTest
QuickFinder COVID-19/Flu Antigen Pro Test detects and distinguishes antigens from SARS-CoV-2 and influenza A and B in anterior nasal swabs. It is used for symptomatic individuals, with self…
QuickFinder COVID-19/Flu Antigen Pro Test detects and distinguishes antigens from SARS-CoV-2 and influenza A and B in anterior nasal swabs. It is used for symptomatic individuals, with self collection from age 14 or adult collection from age two. The described sample window is the first four days of symptoms.
The cassette uses lateral flow antibodies to capture viral proteins as the sample moves across a membrane. Coloured lines identify the corresponding viral targets, while a control line indicates that the test has run as intended. It provides a qualitative result from a direct sample without transport medium.
Listed Item
25 Test Kit / Box
Result Limits
A negative result is presumptive and does not rule out infection. A healthcare provider may determine that confirmation with a cleared molecular test is appropriate. Positive results also do not exclude another respiratory infection.
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 | 2025-03-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 30 °C; Handling environment temperature 36 to 86 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 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 |
| 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 |
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.