Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3982](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3982) → QVF — Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

# QVF · Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

_Microbiology · 21 CFR 866.3982 · Class 2_

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

## Overview

- **Product Code:** QVF
- **Device Name:** Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- **Regulation:** [21 CFR 866.3982](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3982)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## 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.

## Classification Rationale

Class II (special controls). The device is a simple qualitative device to directly detect SARS-CoV-2 virus targets in human clinical specimens for settings operating under a certificate of waiver or at home use.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251289](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/K251289.md) | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | Oct 22, 2025 | SESE |
| [K243872](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/K243872.md) | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | Jun 16, 2025 | SESE |
| [K250273](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/K250273.md) | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | Jun 13, 2025 | SESE |
| [K233358](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/K233358.md) | SCoV-2 Ag Detect Rapid Test | InBios International, Inc. | Aug 23, 2024 | SESE |
| [K232377](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/K232377.md) | Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC | Apr 19, 2024 | SESE |
| [K231187](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/K231187.md) | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | Jan 23, 2024 | SESE |
| [K233688](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/K233688.md) | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | Dec 13, 2023 | SESE |
| [DEN220039](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QVF/DEN220039.md) | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | Mar 8, 2023 | DENG |

## Top Applicants

- Quidel Corporation — 2 clearances
- Abbott Diagnostics Scarborough, Inc. — 1 clearance
- Becton, Dickinson and Company — 1 clearance
- Guangzhou Wondfo Biotech Co., Ltd. — 1 clearance
- Healgen Scientific,, LLC — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com