CliniMACS CD34 Reagent
Basic Information
- Brand Name
- CliniMACS CD34 Reagent
- Primary DI
- 04049934004827
- Version / Model
- 70103
- Catalog Number
- 171-01
- Company Name
- Miltenyi GmbH
- Labeler DUNS
- 327036034
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-26
- Public Version
- 4
- Public Version Date
- 2021-03-01
- Public Version Status
- Update
- Public Device Record Key
- 86d95199-b7cc-428a-946b-563bfa6055b0
Device Description
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OVG | Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049934004827 | GS1 |
Customer Contacts
- Phone
- 800-810-3135
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BH110018 | 0 |