AvailABIlity:Europe(1),USA(2),other(3)
Content:1setOverview
Clini
MACS?DepletionTubingSetscontaintubingwithapre-assembledCellCollectionBag,ReapplicationBag,Non-TargetCellBag,andBufferWasteBag.
Thefluidpathofthetubingsetsissterileandnon-pyrogenic.
Onepackageunitcontainsonesealedtubingsetforsingleuse.
TheperformanceoftheCliniMACSDepletionTubingSetsdependsontheindividualCliniMACSSeparationstrategy.Forinformationonrespectivecapacities,refertotheCliniMACSUserManualorcontactyourlocalrepresentative.
PleaseinquireaboutrequiredCliniMACSSystemcomponentsandaccessories.
TheCliniMACSPlusInstrumentwithSoftware
Version2.40orhigherisrequired.
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
Applications
TheCliniMACSDepletionTubingSetisspecificallydesignedfordepletionoflargequantitiesofcellsfromhumanheterogeneoushematologiccellpopulationsincombinationwiththeCliniMACSSystem.
ItisalsodesignedforafasterdepletionofmorecellsascomparedtootherCliniMACSTubingSets.1,2