510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QWRClass II

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

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

QWR is the FDA product code for Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid 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 nucleic acid 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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
QWR
Device name
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
FDA definition
A simple point-of-care device to detect SARS-CoV-2 nucleic acid 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
3
Ingested recalls
2

Clearances, product code QWR

By decision year
3 clearances under product code QWR with a decision year between 2023 and 2025, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QWR by decision year
YearClearances
20232
20251

Applicants with the most clearances

Product code QWR
Applicants holding the most 510(k) clearances under product code QWR
ApplicantClearances
Roche Molecular Systems Inc2
Abbott Diagnostics Scarborough, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code