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, Guangzhou Wondfo Biotech Co., Ltd. and Nano-Ditech Corporation.
FDA 510(k) Cleared Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings Devices (Product Code QVF)
About Product Code QVF - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QVF since 2023, with 7 receiving FDA clearance (average review time: 205 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
FDA review times for QVF submissions have been consistent, averaging 206 days recently vs 205 days historically.
QVF devices are reviewed by the Microbiology panel. Browse all Microbiology devices →