Duns Number:164757242
Device Description: The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic
Catalog Number
-
Brand Name
Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge
Version/Model Number
20-006-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 05, 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
K070597
Product Code
NPQ
Product Code Name
Test, Factor V Leiden Mutations, Genomic Dna Pcr
Public Device Record Key
9f324433-2392-47dc-a0d2-b923649cd640
Public Version Date
December 06, 2019
Public Version Number
4
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 |