CLINIMACS 1000mL PBS/EDTA Buffer For Research Use 130-070-525 3/PK Expired 8/23

This is a CLINIMACS 1000mL PBS/EDTA Buffer For Research Use 130-070-525 3/PK Expired 8/23.

What you will get:

CLINIMACS 1000mL PBS/EDTA Buffer For Research Use 130-070-525 3/PK Expired 8/23

This is my item R111B1S1 4658.  1 item was available at listing time.  List price is $240 from Miltenyi Biotec.  This box has 3 1 liter bags in it.

The last picture shows one of these from another box (that has only 2 in this box).  This partial box is not for sale at this time.

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More Information:

This expired 8/9/2023.

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 ex vivo cell processing only.

CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.


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