Duns Number:956711444
Device Description: Xpert BCR-ABL Ultra test; 10 test kit
Catalog Number
GXBCRABL-US-10
Brand Name
Xpert BCR-ABL Ultra
Version/Model Number
GXBCRABL-US-10
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
K190076
Product Code
OYX
Product Code Name
Bcr/Abl1 Monitoring Test
Public Device Record Key
5b24dea1-190d-4e6c-87a4-6dd2c5474875
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
October 25, 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 | 53 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 78 |