Sars-Cov-2 Serology Test
The 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, intended to aid in identifying individuals who have mounted an adaptive immune response to the virus, such as following infection or vaccination. It is not intended for diagnosing acute SARS-CoV-2 infection or for screening blood and tissue donors. Classified as FDA Class 2 under regulation 866.3983, it requires 510(k) clearance in the Microbiology specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QVP
- Device Class
- FDA class 2
- Regulation Number
- 866.3983
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252280 | Elecsys Anti-SARS-CoV-2 S | Apr 13, 2026 | Substantially Equivalent | Roche Diagnostics |
| K253839 | Elecsys Anti-SARS-CoV-2 | Dec 17, 2025 | Substantially Equivalent | Roche Diagnostics |
| K250768 | Elecsys Anti-SARS-CoV-2 | Jun 10, 2025 | Substantially Equivalent | Roche Diagnostics |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | May 05, 2023 | Unknown | Ortho-Clinical Diagnostics, Inc. |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | May 05, 2023 | Unknown | Ortho-Clinical Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.