Identity
- Trade Name
- CD34-VioBlue FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 170-081-079 FDA UDI
- Description
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133800 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assay development analyte-specific reagent IVD
CD34-VioBlue by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Miltenyi Biotec B.V. & Co. KG
Sources (1)
- FDA UDI 3d443d4d-e84f-4888-8fe5-901570680ccf 35 fields · synced Jun 8, 2026