FDA Product Code QYT: Over-the-counter Covid-19 Antigen Test
Home COVID-19 testing enables immediate self-diagnosis without laboratory infrastructure. FDA product code QYT covers over-the-counter COVID-19 antigen tests for consumer use.
These lateral flow antigen tests provide a rapid visual result for the presence of SARS-CoV-2 antigen in a nasal swab sample within 15 minutes. They are cleared for repeated use by symptomatic and asymptomatic individuals without a healthcare professional.
QYT devices are Class II medical devices, regulated under 21 CFR 866.3984 and reviewed by the FDA Microbiology panel.
Leading manufacturers include ACON Laboratories, Inc., Quidel Corporation and Guangzhou Wondfo Biotech Co., Ltd..
List of Over-the-counter Covid-19 Antigen Test devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Over-the-counter Covid-19 Antigen Test devices (product code QYT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →