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1、COAGULATIONCONTROL-LEVEL2(COAGCONTROL2)CatNo.CG5022LotNo.138CGSize:12x1mlExpiry:2014-07INTENDEDUSEThisproductisintendedforinvitrodiagnosticuseandinthequalitycontrolofcoagulationsystems.TheCoagulationControlsareforthecontrolofaccuracyandprecision.DEVICEDESCRIPTIONTheCoagulationControlsar
2、esuppliedat3levels,level1,2and3.Targetvaluesandrangesaresuppliedfortheanalyteslistedinthevaluessection.SAFETYPRECAUTIONSANDWARNINGSThecontrolsareintendedforinvitrodiagnosticuseonly.Donotpipettebymouth.Exercisethenormalprecautionsrequiredforhandlinglaboratoryreagentsandcontrols.Humansour
3、cematerialwhichhasbeenaddedhasbeentestedatdonorlevelfortheHumanImmunodeficiencyVirus(HIV1,HIV2)antibody,HepatitisBSurfaceAntigen(HbsAg),andHepatitisCVirus(HCV)antibodyandwasfoundtobeNON-REACTIVE.FDAapprovedmethodshavebeenusedtoconductthesetests.However,sincenomethodcanoffercompleteassur
4、anceastotheabsenceofinfectiousagents,thismaterialandallpatientsamplesshouldbehandledasthoughcapableoftransmittinginfectiousdiseasesanddisposedofaccordingly.HealthandSafetyDatasheetsareavailableonrequest.STORAGEANDSTABILITYOPENED:Storerefrigerated(+2°Cto+8°C).APTT,TT,PT,FibrinogenandAnti
5、thrombinIIIinreconstitutedserumarestablefor24hoursat+2°Cto+8°Cifkeptcappedinoriginalcontainerandfreefromcontamination.ProteinC,ProteinS,Plasminogen,andFactorsII,V,VII,VIII,IX,X,XI,XIIarestablefor8hoursat+2°Cto+8°C.Onlytherequiredamountofproductshouldberemoved.Afteruse,anyresidualproduct
6、shouldNOTBERETURNEDtotheoriginalvial.UNOPENED:Storerefrigerated(+2°Cto+8°C).Stabletoexpirationdateprintedonindividualvials.PREPARATIONFORUSETheCoagulationControlsaresuppliedlyophilised.1.Carefullyreconstituteeachvialoflyophilisedcontrolwithexactly1mlofdistilledwaterat+15°Cto+25°C.Closet
7、hebottleandallowtostandfor30minutesbeforeuse.Ensurecontentsarecompletelydissolvedbyswirlinggently.Avoidtheformationoffoam.Donotshakethevial.2.RefertotheControlsectionoftheindividualanalyserapplication.3.Refrigerateanyunusedmaterial.Priortoreuse,mixthecontentsofthevialthoroughly
