Duns Number:878263359
Device Description: Vysis ALK Break Apart FISH Probe Kit
Catalog Number
06N38-020
Brand Name
Vysis
Version/Model Number
06N38-020
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
P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012,P110012
Product Code
OWE
Product Code Name
Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
Public Device Record Key
78a76e44-2d19-4add-b7e4-0c54cd2b4a4b
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
November 20, 2014
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 | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |