DeviceClearance

Product code QVF— Microbiology

BD Veritor System for SARS-CoV-2

Classification name
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Device class
Class 2
Regulation
21 CFR 866.3982
Advisory panel
Microbiology
Total cleared
10
First cleared
Most recent

FDA classification definition

“A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory”

— U.S. Food and Drug Administration, device classification record for product code QVF under 21 CFR 866.3982, via openFDA

Market context for product code QVF

FDA has cleared 10 devices under product code QVF between 2023 and 2026, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QVF

Recent clearances under product code QVF

Data sourced from openFDA. This site is unofficial and independent of the FDA.