Duns Number:255371916
Device Description: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.
Catalog Number
I030B0373
Brand Name
xTAG® CYP2D6 Kit v3
Version/Model Number
I030B0373
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
-
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
K093420,K130189,K170492
Product Code
NTI
Product Code Name
Drug metabolizing enzyme genotyping systems
Public Device Record Key
008729b7-8ea6-46c2-9501-c75db4c00012
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |