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公司地址
苏州工业园区生物纳米园A4#216
联系电话
4000-520-616 / 18915418616
传真号码
0512-67156496
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info@ebiomall.com
公司网址
https://www.ebiomall.com
商品描述
AvailABIlity:Europe(1),USA(2),other(3)
Content:1unit
Content:1unit
Overview
TheCliniMACSProdigy®representsthenextgenerationinautomatedcellprocessing.Thisdeviceoffersadvancedintegratedsolutionstostreamlinecellprocessingworkflowsfromcellseparationthroughcellculturetoformulationofthefinalproduct.
Disclaimer
TheCliniMACS®Systemcomponents,includingReagents,TubingSets,Instruments,andPBS/EDTABuffer,aredesigned,manufacturedandtestedunderaqualitysystemcertifiedtoISO13485.
IntheEU,theCliniMACSSystemcomponentsareavailableasCE-markedmedicaldevicesfortheirrespectiveintendeduse,unlessotherwisestated.TheCliniMACSReagentsandBiotinConjugatesareintendedforinvitrouseonlyandarenotdesignatedfortherapeuticuseordirectinfusionintopatients.TheCliniMACSReagentsincombinationwiththeCliniMACSSystemareintendedtoseparatehumancells.MiltenyiBiotecasthemanufactureroftheCliniMACSSystemdoesnotgiveanyrecommendationsregardingtheuseofseparatedcellsfortherapeuticpurposesanddoesnotmakeanyclaimsregardingaclinicalbenefit.Forthemanufacturinganduseoftargetcellsinhumansthenationallegislationandregulations-e.g.,fortheEUtheDirective2004/23/EC("humantissuesandcells"),ortheDirective2002/98/EC("humanbloodandbloodcomponents")-mustbefollowed.Thus,anyclinicalapplicationofthetargetcellsisexclusivelywithintheresponsibilityoftheuserofaCliniMACSSystem.
IntheUS,theCliniMACSCD34ReagentSystem,includingtheCliniMACSPlusInstrument,CliniMACSCD34Reagent,CliniMACSTubingSetsTSandLS,andtheCliniMACSPBS/EDTABuffer,isFDAapproved;allotherproductsoftheCliniMACSProductLineareavailableforuseonlyunderanapprovedInvestigationalNewDrug(IND)applicationorInvestigationalDeviceExemption(IDE).
CliniMACSMicroBeadsareforresearchuseonlyandnotforhumantherapeuticordiagnosticuse.Unlessotherwisespecificallyindicated,MiltenyiBiotecproductsandservicesareforresearchonlyandnotfortherapeuticordiagnosticuse.
Details
TheCliniMACSProdigyoffersaflexIBLeplatformforcellprocessingapplicationsenablingthemagneticseparationofdifferentcelltypesaswellascustomizedcellprocessingprotocols.
Thecellprocessingunitforfullyautomatedwashing,fractionationandcultivationofcellsrepresentsanintegralcomponentoftheCliniMACSProdigy.Forindividualprocedures,itwillrequireasingle-usechamber,whichisincludedaspartofspecificCliniMACSProdigyTubingSets.ALayerDetectionCameraautomaticallydeterminestheoptimalcellfractionationendpointbydiscerningthemacroscopiclayersofthesourcecellproduct.
ThemagneticcellseparationunitcomprisesasecondintegralcomponentoftheCliniMACSProdigyenablingthemagneticseparationofvirtuallyanycelltype.
Applications
TheCliniMACSProdigyhasbeendevelopedasanintegratedcellprocessingdeviceinordertoautomateandstandardizethecompletemanufacturingprocessofcellularproducts:
- Fractionationofstartingmaterial
- Cellwashing
- Targetcelllabeling
- Magneticcellseparation
- Cellcultivation
- Volumereduction
- Finalproductformulation
