Panels › Microbiology › Product code QVP · Class 2
Sars-Cov-2 Serology Test
Regulation 866.3983
2510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QVP
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 3 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 13, 2026 | K252280 | Elecsys Anti-SARS-CoV-2 S Roche Diagnostics | QVP |
| Dec 17, 2025 | K253839 | Elecsys Anti-SARS-CoV-2 Roche Diagnostics | QVP |
| Jun 10, 2025 | K250768 | Elecsys Anti-SARS-CoV-2 Roche Diagnostics | QVP |
| May 5, 2023 | DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 To Ortho-Clinical Diagnostics, Inc. | QVP |
| May 5, 2023 | DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Ortho-Clinical Diagnostics, Inc. | QVP |
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