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QVFClass II

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

21 CFR 866.3982 / Microbiology
FDA source (opens on fda.gov)

QVF is the FDA product code for Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings, a class II device type, regulated under 21 CFR 866.3982. FDA's definition for this code reads: "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...". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QVF
Device name
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
FDA 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
Regulation
21 CFR 866.3982
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
0

Clearances, product code QVF

By decision year
10 clearances under product code QVF with a decision year between 2023 and 2026, 2024 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QVF by decision year
YearClearances
20232
20243
20253
20262

Applicants with the most clearances

Product code QVF
Applicants holding the most 510(k) clearances under product code QVF
ApplicantClearances
Ortho-Clinical Diagnostics, Inc.2
Abbott Diagnostics Scarborough, Inc.1
Becton Dickinson & Co1
CorDx, Inc.1
Guangzhou Wondfo Biotech Co., Ltd.1
Healgen Scientific LLC1
Inbios International, Inc.1
Nano-Ditech Corporation1
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order