Duns Number:965476641
Device Description: The VERIGENE® II System is an in vitro diagnostic (IVD) platform that performs nucleic aci The VERIGENE® II System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The VERIGENE II System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as automated amplification, array hybridization, and detection of target nucleic acid sequences.
Catalog Number
-
Brand Name
VERIGENE® II System
Version/Model Number
VERIGENE-II-6M-IVD
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"
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For Single-Use
-
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
-
Product Code
NSU
Product Code Name
Instrumentation for clinical multiplex test systems
Public Device Record Key
edcf186d-0f91-4f2d-918a-e3bc3c488d26
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
December 17, 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 |