DEVICE: CliniMACS CD34 Reagent (04049934004827)
Device Identifier (DI) Information
CliniMACS CD34 Reagent
70103
In Commercial Distribution
171-01
Miltenyi GmbH
70103
In Commercial Distribution
171-01
Miltenyi GmbH
CliniMACS® CD34 Reagent is a dark amber, non-viscous, colloidal solution containing an antibody conjugate in buffer. The conjugate consists of a murine IgG1 monoclonal antibody directed against the Class II epitope of the human CD34 antigen, which is chemically conjugated to dextran beads having an iron oxide/hydroxide core used in conjuction with the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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60243 | Magnetic cell separation system reagent |
A sterile device that is a component of a magnetic cell separation system intended to selectively bind one or more specific epitopes expressed by cells in heterogeneous human cell preparations for the subsequent magnetic separation of a target cell population. The device is an epitope-specific ligand (e.g., monoclonal antibody sourced from a biologically derived cell line, antibody fragment, or recombinant peptide) coupled directly or indirectly to magnetic beads; the bound cells are retained in a magnetic column and separated from the initial cell preparation. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OVG | Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BH110018 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
86d95199-b7cc-428a-946b-563bfa6055b0
March 01, 2021
4
March 26, 2015
March 01, 2021
4
March 26, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-810-3135
Regulatory_Affairs_USA@miltenyibiotec.com
Regulatory_Affairs_USA@miltenyibiotec.com