Miltenyi Biotec 170-076-650 CliniMACS Tubing Set (P/N 76650), Exp. 3-12-2024

Description: Miltenyi Biotec 170-076-650 CliniMACS Tubing Set (P/N 76650), Exp. 3-12-2024 This is a Miltenyi Biotec 170-076-650 CliniMACS Tubing Set (P/N 76650), Exp. 3-12-2024. What you will get: 1 Miltenyi Biotec 170-076-650 CliniMACS Tubing Set (P/N 76650), Exp. 3-12-2024 This is my item N/D 0781. This is new in the box and expired in March of 2024.1 was available at listing time. Miltenyi Biotec sells these for $1,615 each if not expired.Check out my other items where I have a lot of other scientific equipment and accessories for sale.More Information:OverviewCliniMACS® Tubing Sets consist of preassembled tubing including a pre-column and a separation column. The fluid path of the tubing sets is sterile and non-pyrogenic.One package unit contains one sealed tubing set for single use.The performance of the CliniMACS Tubing Sets depends on the individual CliniMACS Separation strategy. For information on respective capacities, refer to the CliniMACS User Manual or contact your local representative.Please inquire about required CliniMACS System components and accessories.Detailed product informationApplicationsThe CliniMACS Tubing Sets for clinical use were developed for the enrichment or depletion of cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System.DisclaimerThe 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.CR/GMP products are for ex vivo cell processing only, and are not intended for human in vivo applications. CR/GMP products are designed, manufactured and tested under an ISO 13485 quality management system and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The manufacturing and testing of CR/GMP products of biological origin are in compliance with EP chapter 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”. CliniMACS® Tubing SetsCliniMACS Tubing Set 170-076-650 (165-01)CliniMACS Tubing Set LS 170-076-651 (168-01)CliniMACS Depletion Tubing Set 170-076-652 (266-01)CAUTION:The CliniMACS Tubing Sets are for ex vivo cell processing only, and are not intended for human in vivo applications.ContentsOne CliniMACS Tubing Set or one CliniMACS Tubing SetLS or one CliniMACS Depletion Tubing SetIntended purposeThe tubing set is intended for in vitro pre-separation or processingof human cells from heterogeneous cell populations in combinationwith the CliniMACS Plus System only.LimitationMiltenyi Biotec as the manufacturer of the CliniMACS System doesnot give any recommendations regarding the use of the separatedcells.DisclaimerThe CliniMACS Tubing sets are for ex vivo cell processing only andare not intended for human in vivo applications. For regulatorystatus in the USA, contact your local representative.Quality StatementThe CliniMACS Tubing Sets are manufactured and tested under aquality management system (ISO 13485) and are in compliancewith relevant GMP guidelines. They are designed following therecommendations of USP <1043> on ancillary materials.PrecautionsThe corresponding CliniMACS Plus user manual mustbe observed.Aseptic working procedures must be applied for theunpacking, assembly, and use of the tubing set.After installation of the tubing set check all luerconnections for tightness. If necessary retighten theluer connections.For the manufacturing and use of target cells inhumans the national legislation and regulations mustbe observed. Thus, any clinical application of the targetcells is exclusively within the responsibility of the userof a CliniMACS System.The processing of cells using the tubing set must beperformed by trained operators only.All materials that have been in contact with blood orblood components must be treated and disposed asbiohazardous materials. Therefore, standard hospitalor institutional requirements and national legislationsmust be observed.For additional safety, the integrity test must beperformed as described in the CliniMACS Plus usermanual. If the CliniMACS Plus Instrument is equippedwith software version 2.2x, contact the Miltenyi BiotecInstrument Service for further Information.WarningsDo not use after the use-by date printed on the productlabel.Do not use if package is damaged. Before opening,inspect the packaging for damage, punctures, or tears.Use the product only if package is undamaged andsealed.Do not use if the tubing set is damaged. Do not use, ifany leakage of the product is observed during primingand separation.Do not connect the tubing set directly to the patient.Do not store blood, blood fractions, or cell fractions inthe tubing set.Do not re-use. The re-use of the tubing sets or parts ofthem leads to the endangerment of the patient due tobiological contamination or to inefficient cellseparation.StorageThe tubing set must be stored at room temperature(+15 °C to +30 °C [+59 °F to +86 °F]).Further informationThe tubing set is sterilized with ethylene oxide.The tubing set contains a non-pyrogenic, sterile fluidpath.Please use the shipping calculator to determine shipping. Check out my other items! If you receive your item and it is not to your 100 Percent Satisfaction, please contact us before leaving feedback. I strive to make sure every transaction is a positive one! IF you have a problem with my item, I would like you to use the "Contact Seller" link in the listing, or call me. Please don't open a case. Cases count against me even if they are resolved. I stand behind my items and will work out any problems that you may have with an item. So please contact me if you have a problem with an item I have sold you and don't use the eBay Case as a means of communication. International Buyers, Please Note: Import duties, taxes and charges are not included in the item price or shipping charges. These charges are the buyer's responsibility. Please check with your country's customs office to determine what these additional costs will be prior to bidding/buying. These charges are normally collected by the delivering freight (shipping) company or when you pick the item up do not confuse them for additional shipping charges. We do not mark merchandise values below value or mark items as "gifts". US and International government regulations prohibit such behavior. Powered by SixBit's eCommerce Solution

Price: 400 USD

Location: Natick, Massachusetts

End Time: 2024-11-15T23:35:19.000Z

Shipping Cost: N/A USD