Duns Number:342920388
Device Description: 4E3 recognizes the human CD25 antigen, a 55 kDa glycoprotein also known as the low-affinit 4E3 recognizes the human CD25 antigen, a 55 kDa glycoprotein also known as the low-affinity interleukin-2 receptor alpha chain (IL-2Rα). CD25 is expressed on activated T and B cells, on macrophages, and on a subset of non-activated CD4+ regulatory T cells. The CD25 antigen contains three epitope regions called A, B, and C. This CD25 antibody recognizes epitope region B.
Catalog Number
-
Brand Name
CD25-APC (Clone 4E3)
Version/Model Number
170-081-050
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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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
07e53c15-b0cf-4a4e-b089-84fe82111594
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 26, 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 | 88 |