Atlas FDA

QYT

14 FDA 510(k) clearances · Product code

179 daysmedian time to decision
276 days90th percentile
14clearances measured

FDA profile

Official device name
Over-The-Counter Covid-19 Antigen Test
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3984
Medical specialty
Microbiology
FDA definition
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Adverse events (MAUDE)
2024: 23 · 2025: 83 · 2026: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test (K260754)Assure Tech., LLC2026-06-05
Heal-Check Rapid COVID-19 Antigen Self-Test (K260095)Healgen Scientific,, LLC2026-04-13
GenBody COVID-19 Ag Home Test (K251916)Genbody.Inc.2026-03-13
COVID-19 Detect Rapid Self -Test (K251595)InBios International, Inc.2025-10-12
GenaCheck COVID-19 Rapid Self-Test (K251753)Genabio Diagnostics, Inc.2025-09-05
OHC COVID-19 Antigen Self Test (K241313)Osang, LLC2025-05-30
BinaxNOW™ COVID-19 Antigen Self Test (K243518)Abbott Diagnostics Scarborough, Inc.2025-02-11
CareSuperb™ COVID-19 Antigen Home Test (K241915)Access Bio, Inc.2025-01-29
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (K241317)Guangzhou Wondfo Biotech Co., Ltd.2024-09-30
CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (K240728)CorDx, Inc.2024-06-21
iHealth COVID-19 Antigen Rapid Test (K233842)Ihealth Labs, Inc.2024-05-31
Flowflex® Plus COVID-19 Home Test (K233373)ACON Laboratories, Inc.2024-04-19
QuickVue COVID-19 Test (K231795)Quidel Corporation2024-03-22
Flowflex COVID-19 Antigen Home Test (K230828)ACON Laboratories, Inc.2023-11-09

Track QYT automatically

Every clearance here is in the API, with alerts when new ones post.