Regulatorystatus:Forresearchuseonly
AvailABIlity:worldwide(2)
Content:1setOverview
Clini
MACS?ProdigyTubingSetsformagneticcellseparationconsistofpre-assembledtubingincludingseparationcolumns,acentrifugationchamber,andasetofspecificbags.TheCliniMACSProdigyTS500andTS510TubingSetsareadditionallyequippedwithaHeatExchangeCartridge.Thefluidpathofthetubingsetsissterileandnon-pyrogenic.
Onepackageunitcontainsonesealedtubingsetforsingleuse.
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
CliniMACS?ProdigyTubingSetsformagneticcellseparationweredevelopedfortheprocessingofcellsfromhumanheterogeneoushematologicalcellpopulationsincombinationwiththeCliniMACSProdigyandothercomponentsoftheCliniMACSSystem.
Forinformationonthedifferentapplicationsrefertotheapplication-specificCliniMACSProdigyUserManualsorcontactyourlocalrepresentative.