QYT
- Product code
- QYT
- Device name
- Over-The-Counter Covid-19 Antigen Test
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3984
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 14
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 14 (all years; only the last 3 years are listed here)
FDA classification definition
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260754 | 2026-06-05 | Assure Tech., LLC | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-… | |
| K260095 | 2026-04-13 | Healgen Scientific,, LLC | Heal-Check Rapid COVID-19 Antigen Self-Test | |
| K251916 | 2026-03-13 | Genbody.Inc. | GenBody COVID-19 Ag Home Test | |
| K251595 | 2025-10-12 | InBios International, Inc. | COVID-19 Detect Rapid Self -Test | FDA |
| K251753 | 2025-09-05 | Genabio Diagnostics, Inc. | GenaCheck COVID-19 Rapid Self-Test | |
| K241313 | 2025-05-30 | Osang, LLC | OHC COVID-19 Antigen Self Test | |
| K243518 | 2025-02-11 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Antigen Self Test | |
| K241915 | 2025-01-29 | Access Bio, Inc. | CareSuperb COVID-19 Antigen Home Test | |
| K241317 | 2024-09-30 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | |
| K240728 | 2024-06-21 | CorDx, Inc. | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 … | |
| K233842 | 2024-05-31 | Ihealth Labs, Inc. | iHealth COVID-19 Antigen Rapid Test | |
| K233373 | 2024-04-19 | ACON Laboratories, Inc. | Flowflex® Plus COVID-19 Home Test | — |
| K231795 | 2024-03-22 | Quidel Corporation | QuickVue COVID-19 Test | |
| K230828 | 2023-11-09 | ACON Laboratories, Inc. | Flowflex COVID-19 Antigen Home Test | — |
Official FDA classification page: QYT
Classification and pathway per current FDA publications. Data from openFDA (CC0).