BinaxNOW COVID-19 Ag Card
FDA 510(k) clearance K250273 · decided 2025-06-13
Clearance details
- K-number
- K250273
- Device name
- BinaxNOW COVID-19 Ag Card
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-30
- Decision date
- 2025-06-13
- Days to decision
- 134 days
- Clearance type
- Dual Track
- Product code
- QVF
- Device class
- 2
- Regulation number
- 866.3982
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| CorDx Tyfast COVID-19 Ag Rapid Test Rx (K253882) | CorDx, Inc. | 2026-06-01 |
| WELLlife COVID-19 Antigen Test Rx (K251289) | Guangzhou Wondfo Biotech Co., Ltd. | 2025-10-22 |
| BD Veritor System for SARS-CoV-2 (K243872) | Becton, Dickinson and Company | 2025-06-16 |
| SCoV-2 Ag Detect Rapid Test (K233358) | InBios International, Inc. | 2024-08-23 |
| Healgen Rapid COVID-19 Antigen Test (K232377) | Healgen Scientific,, LLC | 2024-04-19 |
| Nano-Check™ COVID-19 Antigen Test (K231187) | Nano-Ditech Corporation | 2024-01-23 |
| Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (K233688) | Quidel Corporation | 2023-12-13 |
| Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039) | Quidel Corporation | 2023-03-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NMP22 BladderChek Test (P940035/S017) | Abbott Diagnostics Scarborough, Inc. | 2022-07-12 |
| Alere NMP22 BladderChek Test (P940035/S016) | Abbott Diagnostics Scarborough, Inc. | 2021-06-15 |
| Alere NMP22 BladderChek Test (P940035/S015) | Abbott Diagnostics Scarborough, Inc. | 2018-05-17 |
| MATRITECH NMP22(TM) TEST KIT (P940035/S014) | Abbott Diagnostics Scarborough, Inc. | 2017-02-27 |
| Alere NMP22 BladderChek Test (P940035/S013) | Abbott Diagnostics Scarborough, Inc. | 2016-09-08 |
| ALERE NMP22(TM) TEST (P940035/S012) | Abbott Diagnostics Scarborough, Inc. | 2016-05-06 |
| ALERE NMP22 BLADDERCHEK TEST (P940035/S011) | Abbott Diagnostics Scarborough, Inc. | 2015-07-28 |
| ALERE NMP22 TEST (P940035/S010) | Abbott Diagnostics Scarborough, Inc. | 2013-07-16 |