CareSuperb COVID-19 Antigen Home Test
3 catalogue numbers from RCTM-00171, listed by Access Bio, Inc., United States, under Over-The-Counter Covid-19 Antigen Test. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (1), Tianjin (1). 2 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 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
Record
| Listed by | Access Bio, Inc., United States |
|---|---|
| FDA product code | QYT |
| Device type | Over-The-Counter Covid-19 Antigen Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3984 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K241915 |
| Record published | 2026-01-05 |
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 |
|---|---|---|
| RCTM-00171 | In distribution | |
| RCTM-00571 | In distribution | |
| RCTM-00271 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| WELLlife™ | Wondfo USA Co., Ltd. | 12 |
| CorDx Tyfast | Coretests, Inc. | 8 |
| iHealth | iHealth Labs, Inc. | 5 |
| SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 25 Tests/Box | Watmind USA | 4 |
| BinaxNOW COVID-19 Antigen Self Test | Alere Scarborough, Inc. | 4 |
| Case SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box | Watmind USA | 4 |
| equate | Wal Mart Stores, Inc | 2 |
| Retail Display Box – SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tes | Watmind USA | 2 |
| CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box | Watmind USA | 2 |
| CVS Health At Home COVID-19 Test Kit | Diagnostic Hybrids, Inc. | 2 |
| GenaCheck® COVID-19 Rapid Self-Test 20T | Genabio Diagnostics Inc | 1 |
| Flowflex COVID-19 Antigen Home Test | Acon Laboratories, Inc. | 1 |
Showing 12 of 16. All products under Over-The-Counter Covid-19 Antigen Test
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241915 | 2025-01-29 |
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.