FDA Product Code
FDA Product Code QVP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3983
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | 2026-04-13 | Traditional | PDF ↗ |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-12-17 | Special | PDF ↗ |
| K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-06-10 | Traditional | PDF ↗ |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 | Direct | — |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 | Direct | — |
Product code QVP · Class II · Microbiology. Data: openFDA.