CD34-VioBlue
Basic Information
- Brand Name
- CD34-VioBlue
- Primary DI
- 04049934133800
- Version / Model
- 170-081-079
- Company Name
- Miltenyi Biotec B.V. & Co. KG
- Labeler DUNS
- 342920388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-26
- Public Version
- 1
- Public Version Date
- 2021-04-05
- Public Version Status
- New
- Public Device Record Key
- 3d443d4d-e84f-4888-8fe5-901570680ccf
Device 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).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64705 | Assay development analyte-specific reagent IVD | An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049934133800 | GS1 |
Customer Contacts
- Phone
- 800-367-6227
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 2 - 8 °C Protected from light.