QVP
5 FDA 510(k) clearances · Product code
265 daysmedian time to decision
592 days90th percentile
5clearances measured
FDA profile
- Official device name
- Sars-Cov-2 Serology Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3983
- Medical specialty
- Microbiology
- FDA definition
- A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.
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| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-SARS-CoV-2 S (K252280) | Roche Diagnostics | 2026-04-13 |
| Elecsys Anti-SARS-CoV-2 (K253839) | Roche Diagnostics | 2025-12-17 |
| Elecsys Anti-SARS-CoV-2 (K250768) | Roche Diagnostics | 2025-06-10 |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (DEN210040) | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (DEN210038) | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 |
Track QVP automatically
Every clearance here is in the API, with alerts when new ones post.