Duns Number:397134693
Device Description: Mammaglobin (EP249) monoclonal antibody is intended to be used for the qualitative identif Mammaglobin (EP249) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of humanMammaglobin protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system(includes Leica BOND-MAX system and Leica BOND-III system).
Catalog Number
PA0378
Brand Name
BOND™
Version/Model Number
PA0378
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
c9dee63b-0e53-404e-9088-6ee57b0380d3
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 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 |