Duns Number:833074623
Device Description: Anti CD45 Antibody is a mouse monoclonal antibody to CD45 [J33] conjugated with Phycoeryth Anti CD45 Antibody is a mouse monoclonal antibody to CD45 [J33] conjugated with Phycoerythrin-Cyanine 7
Catalog Number
U31075
Brand Name
Anti CD45 Antibody
Version/Model Number
U31075
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
f539533a-4cef-4749-a20f-c5f52dd88abc
Public Version Date
February 13, 2020
Public Version Number
1
DI Record Publish Date
February 05, 2020
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 | 4 |