QYT · Over-The-Counter Covid-19 Antigen Test
Microbiology · 21 CFR 866.3984 · Class 2
Overview
| Product Code | QYT |
|---|---|
| Device Name | Over-The-Counter Covid-19 Antigen Test |
| Regulation | 21 CFR 866.3984 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | Apr 13, 2026 | SESE |
| K251916 | GenBody COVID-19 Ag Home Test | Genbody.Inc. | Mar 13, 2026 | SESE |
| K251595 | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | Oct 12, 2025 | SESE |
| K251753 | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. | Sep 5, 2025 | SESE |
| K241313 | OHC COVID-19 Antigen Self Test | Osang, LLC | May 30, 2025 | SESE |
| K243518 | BinaxNOW COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | Feb 11, 2025 | SESE |
| K241915 | CareSuperb COVID-19 Antigen Home Test | Access Bio, Inc. | Jan 29, 2025 | SESE |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. | Sep 30, 2024 | SESE |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. | Jun 21, 2024 | SESE |
| K233842 | iHealth COVID-19 Antigen Rapid Test | Ihealth Labs, Inc. | May 31, 2024 | SESE |
| K233373 | Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. | Apr 19, 2024 | SESE |
| K231795 | QuickVue COVID-19 Test | Quidel Corporation | Mar 22, 2024 | SESE |
| K230828 | 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
