Product code QWR— Microbiology
ID NOW COVID-19 2.0
- Classification name
- Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
- Device class
- Class 2
- Regulation
- 21 CFR 866.3982
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QWR
FDA has cleared devices under product code QWR between 2023 and 2025, filed by 2 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
- 2025
- 2023
Top applicants under product code QWR
Recent clearances under product code QWR
Data sourced from openFDA. This site is unofficial and independent of the FDA.