Product code QYT— Microbiology
BinaxNOW COVID-19 Antigen Self Test
- Classification name
- Over-The-Counter Covid-19 Antigen Test
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Total cleared
- 14
- First cleared
- Most recent
FDA classification definition
“For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.”
Market context for product code QYT
FDA has cleared devices under product code QYT between 2023 and 2026, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2024
- 2023
Top applicants under product code QYT
Recent clearances under product code QYT
- K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
- K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test
- K251916 — GenBody COVID-19 Ag Home Test
- K251595 — COVID-19 Detect Rapid Self -Test
- K251753 — GenaCheck COVID-19 Rapid Self-Test
- K241313 — OHC COVID-19 Antigen Self Test
- K243518 — BinaxNOW COVID-19 Antigen Self Test
- K241915 — CareSuperb COVID-19 Antigen Home Test
- K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
- K233842 — iHealth COVID-19 Antigen Rapid Test
- K233373 — Flowflex® Plus COVID-19 Home Test
- K231795 — QuickVue COVID-19 Test
- K230828 — Flowflex COVID-19 Antigen Home Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.