FDA product code QVP: Sars-Cov-2 Serology Test
QVP is the FDA product code for sars-cov-2 serology test. It is a Class II device, regulated under 21 CFR 866.3983 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QVP, 3 in the last five years. The average 510(k) review took 123 days (median 89); 158 days on average over the last three years. 2 De Novo requests were granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Sars-Cov-2 Serology Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3983 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QVP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 52 |
| 2026 | 1 | 265 |
Compare with all 510(k) review times · Search every QVP clearance
Top QVP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 3 | 2026-04-13 |
Most recent QVP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252280 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 S | 2026-04-13 | 265 |
| K253839 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 | 2025-12-17 | 16 |
| K250768 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 | 2025-06-10 | 89 |
Recalls for QVP devices
openFDA lists no recalls for product code QVP.
Frequently asked questions
What is FDA product code QVP?
QVP is the FDA product code for sars-cov-2 serology test. It is a Class II device, regulated under 21 CFR 866.3983 and reviewed by the Microbiology panel.
What device class is QVP?
Class II, regulation 21 CFR 866.3983. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVP?
Across 3 cleared submissions the average was 123 days from receipt to decision (median 89).
Which companies have the most QVP clearances?
Roche Diagnostics (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QVP
- Run a recall and safety report across every QVP manufacturer
- Watch product code QVP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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