Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3983](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3983) → QVP — Sars-Cov-2 Serology Test

# QVP · Sars-Cov-2 Serology Test

_Microbiology · 21 CFR 866.3983 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP

## Overview

- **Product Code:** QVP
- **Device Name:** Sars-Cov-2 Serology Test
- **Regulation:** [21 CFR 866.3983](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3983)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is a qualitative chemiluminescent immunoassay intended for the detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA). It is performed on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

## Classification Rationale

Class II (special controls). The device is classified under 21 CFR 866.3983, SARS-CoV-2 serology test, and is subject to special controls to mitigate risks such as false test results, failure to correctly interpret results, and failure to correctly operate the device.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252280](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/K252280.md) | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | Apr 13, 2026 | SESE |
| [K253839](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/K253839.md) | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | Dec 17, 2025 | SESE |
| [K250768](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/K250768.md) | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | Jun 10, 2025 | SESE |
| [DEN210040](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/DEN210040.md) | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Ortho-Clinical Diagnostics, Inc. | May 5, 2023 | DENG |
| [DEN210038](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/DEN210038.md) | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | Ortho-Clinical Diagnostics, Inc. | May 5, 2023 | DENG |

## Top Applicants

- Roche Diagnostics — 3 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP)

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