← Product Code [QVP](/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP) · K252280

# Elecsys Anti-SARS-CoV-2 S (K252280)

_Roche Diagnostics · QVP · Apr 13, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/K252280

## Device Facts

- **Applicant:** Roche Diagnostics
- **Product Code:** [QVP](/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP.md)
- **Decision Date:** Apr 13, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3983
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/K252280](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVP/K252280)

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