Duns Number:397134693
Device Description: NCL-L-AE1/AE3-601 is intended for the qualitative identification by light microscopy of hu NCL-L-AE1/AE3-601 is intended for the qualitative identification by light microscopy of human cytokeratins 56.5, 50, 50’, 48 and 40 kDof the acidic subfamily and 65 to 67, 64, 59, 58, 56 and 52 kD of the basic subfamily in paraffin sections.
Catalog Number
NCL-L-AE1/AE3-601
Brand Name
Novocastra™
Version/Model Number
AE1/AE3-601-L-CE
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
-
Product Code
NJT
Product Code Name
Immunohistochemistry Reagents And Kits
Public Device Record Key
9550d7ec-f85f-4721-9431-1ad24d02a9f9
Public Version Date
May 25, 2021
Public Version Number
1
DI Record Publish Date
May 17, 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 | 365 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| 3 | A medical device with high risk that requires premarket approval | 1 |