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产品资料

MACS(美天旎)/
CliniMACS
CliniMACS®TubingSetsconsistofpreassembledtubingincludingapre-columnandaseparationcolumn.Thefluidpathofthetubingsetsissterileandnon-pyrogenic.
Onepackageunitcontainsonesealedtubingsetforsingleuse.
TheperformanceoftheCliniMACSTubingSetsdependsontheindividualCliniMACSSeparationstrategy.Forinformationonrespectivecapacities,refertotheCliniMACSUserManualorcontactyourlocalrepresentative.
PleaseinquireaboutrequiredCliniMACSSystemcomponentsandaccessories.

Disclaimer

TheCliniMACS
®
Systemcomponents,includingReagents,TubingSets,Instruments,andPBS/EDTABuffer,aredesigned,manufacturedandtestedunderaqualitysystemcertifiedtoISO13485.
IntheEU,theCliniMACSSystemcomponentsareavailableasCE-markedmedicaldevicesfortheirrespectiveintendeduse,unlessotherwisestated.TheCliniMACSReagentsandBiotinConjugatesareintendedfor
invitro
useonlyandarenotdesignatedfortherapeuticuseordirectinfusionintopatients.TheCliniMACSReagentsincombinationwiththeCliniMACSSystemareintendedtoseparatehumancells.MiltenyiBiotecasthemanufactureroftheCliniMACSSystemdoesnotgiveanyrecommendationsregardingtheuseofseparatedcellsfortherapeuticpurposesanddoesnotmakeanyclaimsregardingaclinicalbenefit.Forthemanufacturinganduseoftargetcellsinhumansthenationallegislationandregulations-e.g.,fortheEUtheDirective2004/23/EC("humantissuesandcells"),ortheDirective2002/98/EC("humanbloodandbloodcomponents")-mustbefollowed.Thus,anyclinicalapplicationofthetargetcellsisexclusivelywithintheresponsibilityoftheuserofaCliniMACSSystem.
IntheUS,theCliniMACSCD34ReagentSystem,includingtheCliniMACSPlusInstrument,CliniMACSCD34Reagent,CliniMACSTubingSetsTSandLS,andtheCliniMACSPBS/EDTABuffer,isFDAapprovedasaHumanitarianUseDevice(HUD),authorizedbyU.S.Federallawforuseinthetreatmentofpatientswithacutemyeloidleukemia(AML)infirstcompleteremission.Theeffectivenessofthedeviceforthisindicationhasnotbeendemonstrated.OtherproductsoftheCliniMACSProductLineareavailableforuseonlyunderanapprovedInvestigationalNewDrug(IND)application,InvestigationalDeviceExemption(IDE)orFDAapproval.
CliniMACSGMPMicroBeadsareforresearchuseand
exvivo
cellprocessingonly.
CliniMACSMicroBeadsareforresearchuseonlyandnotforhumantherapeuticordiagnosticuse.

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