Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
FDA 510(k) clearance K233688 · decided 2023-12-13
Clearance details
- K-number
- K233688
- Device name
- Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
- Applicant
- Quidel Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-11-17
- Decision date
- 2023-12-13
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- QVF
- Device class
- 2
- Regulation number
- 866.3982
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| BinaxNOW COVID-19 Ag Card (K250273) | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 |
| 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 (DEN220039) | Quidel Corporation | 2023-03-08 |
Recalls involving this device
No recalls on record reference this clearance.