QYT — Over-The-Counter Covid-19 Antigen Test Class II
Classification Details
- Product Code
- QYT
- Device Class
- Class II
- Regulation Number
- 866.3984
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251916 | genbody | GenBody COVID-19 Ag Home Test | March 13, 2026 |
| K251595 | inbios international | COVID-19 Detect Rapid Self -Test | October 12, 2025 |
| K251753 | genabio diagnostics | GenaCheck COVID-19 Rapid Self-Test | September 5, 2025 |
| K241313 | osang | OHC COVID-19 Antigen Self Test | May 30, 2025 |
| K243518 | abbott diagnostics scarborough | BinaxNOW COVID-19 Antigen Self Test | February 11, 2025 |
| K241915 | access bio | CareSuperb COVID-19 Antigen Home Test | January 29, 2025 |
| K241317 | guangzhou wondfo biotech co | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | September 30, 2024 |
| K240728 | cordx | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | June 21, 2024 |
| K233842 | ihealth labs | iHealth COVID-19 Antigen Rapid Test | May 31, 2024 |
| K233373 | acon laboratories | Flowflex® Plus COVID-19 Home Test | April 19, 2024 |
| K231795 | quidel corporation | QuickVue COVID-19 Test | March 22, 2024 |
| K230828 | acon laboratories | Flowflex COVID-19 Antigen Home Test | November 9, 2023 |