MACS Technology owes its longstanding success to the combination of superparamagnetic nano-sized beads and a very high magnetic gradient within MACS Columns. This combination allows for minimal labeling of target cells and therefore, preservation of cell integrity and characteristics. MACS MicroBeads are biodegradable and compatible with all downstream applications, including cell sorting, flow cytometry, cell culture, functional assays, and molecular analyses.
MACS Technology enables the isolation of a wealth of cell types for immunology, neuroscience, cancer, stem cell, and cardiovascular research. The method is both gentle and effective. Therefore, cells are isolated to high purity at high yields and viability. These are fundamental requirements not only for basic research, but also for the translation of the discoveries into clinical application. Based on MACS Technology, the CliniMACS® System allows researchers and clinicians to explore the potential of specific cell types for the development of novel therapies in the fight against serious diseases, including cancer.
Disclaimer: Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use. MACS® GMP Products are for research use and ex vivo cell culture processing only, and are not intended for human in vivo applications. For regulatory status in the USA, please contact your local representative. MACS GMP Products are manufactured and tested under a quality system certified to ISO 13485 and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The CliniMACS® System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations – e.g. for the EU the Directive 2004/23/EC (“human tissues and cells”), or the Directive 2002/98/EC (“human blood and blood components”) – must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved; all other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE). CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use CliniMACS, CliniMACS Prodigy, MACS, MACSQuant, Tyto and the MACS logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. Copyright © 2018 Miltenyi Biotec B.V. & Co. KG and/or its affiliates. All rights reserved.
CliniMACS CD34 Reagent System:
Humanitarian Device: Authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this indication has not been demonstrated.
Indication and Usage: The CliniMACS CD34 Reagent System is indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-versus-host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission.
Contradiction: Do not use CD34+ cells prepared with the CliniMACS CD34 Reagent System in patients with known hypersensitivity to murine (mouse) proteins or iron dextran.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Warnings: Do not infuse the CliniMACS CD34 Reagent or the CliniMACS PBS/EDTA Buffer into patients directly.