QVP — Sars-Cov-2 Serology Test Class II
FDA product code QVP covers "Sars-Cov-2 Serology Test", a Class II medical device regulated under 21 CFR 866.3983. Submissions are reviewed by the Microbiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QVP
- Device Class
- Class II
- Regulation Number
- 866.3983
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252280 | roche diagnostics | Elecsys Anti-SARS-CoV-2 S | April 13, 2026 |
| K253839 | roche diagnostics | Elecsys Anti-SARS-CoV-2 | December 17, 2025 |
| K250768 | roche diagnostics | Elecsys Anti-SARS-CoV-2 | June 10, 2025 |
| DEN210038 | ortho-clinical diagnostics | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immuno | May 5, 2023 |
| DEN210040 | ortho-clinical diagnostics | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immu | May 5, 2023 |