CareSuperb COVID-19/FluA&B Antigen Combo Home Test
The CareSuperb COVID-19/Flu A&B Antigen Combo Home Test detects and distinguishes antigens from SARS-CoV-2, influenza A and influenza B in an anterior nasal swab. It is for people with…
The CareSuperb COVID-19/Flu A&B Antigen Combo Home Test detects and distinguishes antigens from SARS-CoV-2, influenza A and influenza B in an anterior nasal swab. It is for people with respiratory infection symptoms. Individuals aged 14 or older may test themselves; an adult may test a child aged two or older.
The single use cassette uses a lateral flow immunoassay. Antigens bind to labeled antibodies and move along the strip to produce visible lines for the corresponding virus. A control line confirms sample migration and test validity. Results are read visually ten minutes after the swab is removed.
Interpreting Results
A missing control line makes the test invalid. Negative results are presumptive and do not rule out infection; a healthcare provider may determine that molecular confirmation is appropriate. Positive results do not exclude another infection at the same time.
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 | Access Bio, Inc., 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 | Manufacturer, Exporter |
| 510(k) | K251604 |
| Record published | 2025-12-24 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RCUM-00571 | 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 |
|---|---|
| K251604 | 2025-08-22 |
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.