Healgen
Healgen COVID-19 FLU A/B Combo De Novo Test
4manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Healgen Scientific Limited Liability Company |
|---|---|
| FDA product code | SCA |
| Device type | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3987 |
| 510(k) | DEN240029 |
| Record published | 2025-02-28 |
| Record revised | 2025-11-24 (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 |
| Packaging | Inner pack, case of 360, inner pack of 4, case of 120, inner pack of 2, case of 300 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GCFC-525SKa-H1 | In distribution | |
| GCFC-525SKa-H4 | In distribution | |
| GCFC-525SKa-H2 | 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 |
| 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
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.