Panels › Microbiology › Product code QVF · Class 2
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Regulation 866.3982
2510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QVF
| Company | 510(k)s | Recalls |
|---|---|---|
| Quidel Corporation | 2 | 0 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 0 |
| Becton, Dickinson and Company | 1 | 0 |
| CorDx, Inc. | 1 | 0 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 0 |
| Healgen Scientific,, LLC | 1 | 0 |
| InBios International, Inc. | 1 | 0 |
| Nano-Ditech Corporation | 1 | 0 |
| Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2026 | K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | QVF |
| Jun 1, 2026 | K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx CorDx, Inc. | QVF |
| Oct 22, 2025 | K251289 | WELLlife COVID-19 Antigen Test Rx Guangzhou Wondfo Biotech Co., Ltd., CN | QVF |
| Jun 16, 2025 | K243872 | BD Veritor System for SARS-CoV-2 Becton, Dickinson and Company | QVF |
| Jun 13, 2025 | K250273 | BinaxNOW COVID-19 Ag Card Abbott Diagnostics Scarborough, Inc. | QVF |
| Aug 23, 2024 | K233358 | SCoV-2 Ag Detect Rapid Test InBios International, Inc. | QVF |
| Apr 19, 2024 | K232377 | Healgen Rapid COVID-19 Antigen Test Healgen Scientific,, LLC | QVF |
| Jan 23, 2024 | K231187 | Nano-Check COVID-19 Antigen Test Nano-Ditech Corporation | QVF |
| Dec 13, 2023 | K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set Quidel Corporation | QVF |
| Mar 8, 2023 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set Quidel Corporation | QVF |
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