Duns Number:184042521
Catalog Number
07494190001
Brand Name
VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody
Version/Model Number
07494190001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NJT
Product Code Name
IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
Public Device Record Key
c086f185-1d0a-4935-a413-3c567886fd01
Public Version Date
February 11, 2021
Public Version Number
1
DI Record Publish Date
February 03, 2021
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 | 134 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |
3 | A medical device with high risk that requires premarket approval | 7 |