Duns Number:080778937
Device Description: The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qual The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
Catalog Number
20-011-024
Brand Name
Respiratory Pathogens Flex (RP Flex) Amplification Tray
Version/Model Number
20-011-024
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K143653,K143653
Product Code
OCC
Product Code Name
Respiratory virus panel nucleic acid assay system
Public Device Record Key
3b3fbca1-07ba-4cf2-a61f-855a1c7b4826
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
December 05, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |