Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3984](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3984) → QYT — Over-The-Counter Covid-19 Antigen Test

# QYT · Over-The-Counter Covid-19 Antigen Test

_Microbiology · 21 CFR 866.3984 · Class 2_

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

## Overview

- **Product Code:** QYT
- **Device Name:** Over-The-Counter Covid-19 Antigen Test
- **Regulation:** [21 CFR 866.3984](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3984)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260095](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K260095.md) | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | Apr 13, 2026 | SESE |
| [K251916](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K251916.md) | GenBody COVID-19 Ag Home Test | Genbody.Inc. | Mar 13, 2026 | SESE |
| [K251595](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K251595.md) | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | Oct 12, 2025 | SESE |
| [K251753](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K251753.md) | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. | Sep 5, 2025 | SESE |
| [K241313](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K241313.md) | OHC COVID-19 Antigen Self Test | Osang, LLC | May 30, 2025 | SESE |
| [K243518](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K243518.md) | BinaxNOW™ COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | Feb 11, 2025 | SESE |
| [K241915](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K241915.md) | CareSuperb™ COVID-19 Antigen Home Test | Access Bio, Inc. | Jan 29, 2025 | SESE |
| [K241317](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K241317.md) | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. | Sep 30, 2024 | SESE |
| [K240728](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K240728.md) | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. | Jun 21, 2024 | SESE |
| [K233842](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K233842.md) | iHealth COVID-19 Antigen Rapid Test | Ihealth Labs, Inc. | May 31, 2024 | SESE |
| [K233373](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K233373.md) | Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. | Apr 19, 2024 | SESE |
| [K231795](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K231795.md) | QuickVue COVID-19 Test | Quidel Corporation | Mar 22, 2024 | SESE |
| [K230828](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K230828.md) | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | Nov 9, 2023 | SESE |

## Top Applicants

- ACON Laboratories, Inc. — 2 clearances
- Abbott Diagnostics Scarborough, Inc. — 1 clearance
- Access Bio, Inc. — 1 clearance
- CorDx, Inc. — 1 clearance
- Genabio Diagnostics, Inc. — 1 clearance

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

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