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 as a Humanitarian Use Device (HUD), 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. Other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or FDA approval.
CliniMACS GMP MicroBeads are for research use and ex vivo cell processing only.
CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.
CryoMACS Freezing Bags are manufactured by Miltenyi Biotec B.V. & Co. KG and controlled under a quality system certified to ISO 13485. These products are available in Europe as CE-marked medical devices and are marketed in the USA under FDA 510(k) clearance.
All products of the TheraSorb product line are designed, manufactured and tested under a quality system certified to ISO 13485 and are available as CE-marked medical devices in the EU. In the US, select TheraSorb products are available for investigational use under an approved Investigational Device Exemption (IDE) or FDA approval.
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.
MACS IVD Antibodies are for in vitro diagnostic use, and are not intended for human in vivo applications. In the EU, MACS IVD Antibodies are available as CE-marked in vitro diagnostic medical devices and meet the requirements of the European directive 98/79/EC on in vitro diagnostic medical devices (IVDD). MACS IVD Antibodies are designed and manufactured under a quality system certified to ISO 13485. These products are not available for use in the United States.
Analyte specific reagents (ASRs) are restricted devices under section 520 (e) of the Federal Food, Drugs, and Cosmetic act. Except as a component of an approved/cleared test, analytical and performance characteristics are not established.