QYT — Over-The-Counter Covid-19 Antigen Test Class II
FDA product code QYT covers "Over-The-Counter Covid-19 Antigen Test", a Class II medical device regulated under 21 CFR 866.3984. Submissions are reviewed by the Microbiology panel. At least 14 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260754 | assure tech | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | June 5, 2026 |
| K260095 | healgen scientific | Heal-Check Rapid COVID-19 Antigen Self-Test | April 13, 2026 |
| 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 |