AvailABIlity:Europe(1),USA(2),other(3)
Content:1unitOverview
Theuser-friendlykeycomponentsoftheClini
MACS®PlusInstrumentoffersophisticatedapplicationsforawholevarietyofseparations.Theselectedstemcells,monocytes,DCs,NKcells,Bcells,andTcellsubsetsallowresearchinthefieldofregenerativemedicine,adoptiveimmunotherapy,andgraftengineering.
- Fullsystemcontrolbymeansofanintegratedmicrocomputer
- Automatizedcellseparationbyamagneticseparationunitincludingbothamovablepermanentmagnetandaholderfortheseparationcolumn
- Aperistalticpumptoensurecontinuityinflowratesthroughoutthetubingset
- VariouspinchvalvestosupporttheperistalticpumpinmanagingthecorrectflowofbufferandcellsUSPension
CellsaremagneticallylabeledintheCellPreparationBagusinganantigen-specificreagent.Subsequently,theCellPreparationBagisconnectedtotheCliniMACSPlusInstrument.Consumer-friendlysoftwarefacilitatestargetcellenrichmentordepletionaswellasfinalcollectionintheCellCollectionBag.TheCliniMACSSystemseparateslargenumbersofcellsprovidingtargetcellswithhighpurityandexcellentyield.Arangeoftubingsetsoptimizedfordifferentapplicationsisavailable.
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.
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