Duns Number:342920388
Device Description: AC136 recognizes the human CD34, a class III epitope of the CD34 antigen. This epitope is AC136 recognizes the human CD34, a class III epitope of the CD34 antigen. This epitope is different than the one recognized by the clone used in the CD34 MicroBead Kits. The CD34 antigen is a single-chain transmembrane glycoprotein, expressed on human hematopoietic stem and progenitor cells, endothelial progenitor cells, vascular endothelial cells, embryonic fibroblasts, and some cells in fetal and adult nervous tissue. The antigen is absent on fully differentiated hematopoietic cells, such as normal peripheral blood lymphocytes, monocytes, granulocytes, erythrocytes, and platelets. Clone AC136 has a similar specificity as the CD34 monoclonal antibody clone 8G12 (HPCA-2). CD34 antibodies can be used for studies of hematopoiesis and nonhematopoietic stem cells, phenotyping of hematopoietic stem cells, and studies on phenotyping of hematologic malignancies, endothelial cells, and endothelial progenitor cells (EPCs).
Catalog Number
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Brand Name
CD34-VioBlue
Version/Model Number
170-081-079
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)
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Over the Counter (OTC)
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Kit
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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
3d443d4d-e84f-4888-8fe5-901570680ccf
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
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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 |