Miltenyi Biotec offers service contracts aimed at meeting the needs of research users. The service contracts include technical support and annual preventive maintenance programs to ensure maximum performance of the CliniMACS instruments over time.
Choose the appropriate level of support:
- Planned Maintenance Contract : A Planned Maintenance Contract includes scheduled maintenance visits. Routinely wearing parts are replaced at no charge. Service costs such as labor and travel fees related to the maintenance visit are covered. In case of a necessary repair, spare parts are provided at a discount.
- Full Service Contract : With this option, all replacement parts, labor, and travel expenses are covered.
- IQ/OQ Services : We provide the necessary official documentation for installation and operational qualifications required to maintain GMP standards.
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. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use.