Duns Number:164757242
Device Description: The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System i The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
Catalog Number
-
Brand Name
Respiratory Virus Plus (RV+) Extraction Tray
Version/Model Number
20-009-020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 21, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103209
Product Code
OCC
Product Code Name
Respiratory Virus Panel Nucleic Acid Assay System
Public Device Record Key
bd09779b-5fe0-486d-b56d-c598118d80a5
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |