Duns Number:342920388
Device Description: AC145 recognizes human CD123, also known as IL-3 receptor alpha-chain. It is the primary l AC145 recognizes human CD123, also known as IL-3 receptor alpha-chain. It is the primary low-affinity subunit of the IL-3 receptor. CD123 associates with CD131, the common beta-chain of the IL-3, IL-5, and GM-CSF receptor, to form the high-affinity IL-3 receptor. The IL-3 receptor is involved in cell signaling for cell growth and differentiation. In peripheral blood, the CD123 antigen is expressed at high levels only on plasmacytoid dendritic cells and basophilic granulocytes but at low levels also on monocytes, eosinophilic granulocytes, myeloid dendritic cells, and subsets of hematopoietic progenitor cells.
Catalog Number
-
Brand Name
CD123-PE
Version/Model Number
170-081-039
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)
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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)
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FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
3d934c43-7df3-4fc9-b87d-9827caee5f05
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 |