The CliniMACS® PBS/EDTA Buffer consists of phosphate buffered saline, pH 7.2, supplemented with 1 mM EDTA.
The buffer is supplied in 1 L or 3 L plastic bags as a sterile, non-pyrogenic solution.

Data and images for
CliniMACS
®
PBS/EDTA Buffer Product Line

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Figure 1

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CliniMACS
®
PBS/EDTA Buffer.

Figure 1

CliniMACS
®
PBS/EDTA Buffer.

Specifications for
CliniMACS
®
PBS/EDTA Buffer Product Line

Overview

The CliniMACS® PBS/EDTA Buffer consists of phosphate buffered saline, pH 7.2, supplemented with 1 mM EDTA.
The buffer is supplied in 1 L or 3 L plastic bags as a sterile, non-pyrogenic solution.

Detailed product information

Applications

The CliniMACS PBS/EDTA Buffer was developed for cell preparation and separation of magnetically labeled cells with the CliniMACS System. CliniMACS PBS/EDTA Buffer is not intended for direct infusion into humans.

Disclaimer

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.

Resources for
CliniMACS
®
PBS/EDTA Buffer Product Line

Certificates

Please follow this
link
to search for Certificates of Analysis (CoA) by lot number.