← Product Code [QVF](/productcode/QVF) · K254264

# Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA (K254264)

_Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · QVF · Sep 4, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K254264

## Device Facts

- **Applicant:** Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- **Product Code:** [QVF](/productcode/QVF.md)
- **Decision Date:** Sep 4, 2026
- **Decision:** SESE
- **Submission Type:** Dual Track
- **Regulation:** 21 CFR 866.3982
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from symptomatic individuals. It is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests.

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**Source:** [https://fda.innolitics.com/device/K254264](https://fda.innolitics.com/device/K254264)

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