FDA Product Code QVF: Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings
Rapid point-of-care COVID-19 testing enables immediate clinical decision-making. FDA product code QVF covers simple point-of-care devices for the direct detection of SARS-CoV-2 antigen.
These lateral flow antigen tests provide a visual result within 15 minutes from a nasal or nasopharyngeal swab without laboratory equipment. They are used in clinical settings, schools, workplaces, and at home to identify infectious individuals rapidly.
QVF devices are Class II medical devices, regulated under 21 CFR 866.3982 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Quidel Corporation, Healgen Scientific, LLC and Becton, Dickinson and Company.
List of Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings devices (product code QVF). 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 →