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, Nano-Ditech Corporation and Healgen Scientific, LLC.
9
Total
8
Cleared
202d
Avg days
2023
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg
169d
recently vs 229d historically
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)
9 devices
Cleared
Jun 01, 2026
CorDx Tyfast COVID-19 Ag Rapid Test Rx
CorDx, Inc.
Microbiology
179d
Cleared
Oct 22, 2025
WELLlife COVID-19 Antigen Test Rx
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology
180d
Cleared
Jun 16, 2025
BD Veritor System for SARS-CoV-2
Becton, Dickinson and Company
Microbiology
181d
Cleared
Jun 13, 2025
BinaxNOW COVID-19 Ag Card
Abbott Diagnostics Scarborough, Inc.
Microbiology
134d
Cleared
Aug 23, 2024
SCoV-2 Ag Detect Rapid Test
InBios International, Inc.
Microbiology
329d
Cleared
Apr 19, 2024
Healgen Rapid COVID-19 Antigen Test
Healgen Scientific, LLC
Microbiology
255d
Cleared
Jan 23, 2024
Nano-Check™ COVID-19 Antigen Test
Nano-Ditech Corporation
Microbiology
272d
Cleared
Dec 13, 2023
Sofia 2 SARS Antigen+ FIA
Quidel Corporation
Microbiology
26d
Not Cleared
Mar 08, 2023
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
Quidel Corporation
Microbiology
265d
About Product Code QVF - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code QVF since 2023, with 8 receiving FDA clearance (average review time: 202 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA 510(k) Review Time - QVF Product Code
Recent submissions under QVF have taken an average of 169 days to reach a decision - down from 229 days historically, suggesting improved FDA processing for this classification.
QVF devices are reviewed by the Microbiology panel. Browse all Microbiology devices →