ࡱ> ikh)`ZZbjbj8h{{-       FFFF,rl0 0000000$1h 4T@0- @0  m0***  0*0**  * }F%l*.000*]4 *]4**\]4 , h*TbX@0@0* 0 d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in vitro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hermo Scientific A5@VW 09B B0 AHN Biotehnologie GmbH A5@VW pipet4u.?0:14V:@>?V?5B:0  V:@>?V?5B:0 70AB>A>2CTBLAO 4;O B>G=>3> 28<V@N20==O >1'T<V2 @V48=8 2 ;01>@0B>@VOE. 1 T<: 0,1 <; &V=0 ?>4V;:8 H:0;8: 0,001 <; >28==0 <0B8 :>;L>@>25 <0@:C20==O.HB205V?5B:0 @87=0G5=V 4;O 28<V@N20==O >1 T<C @V48=8 2 ;01>@0B>@=8E C<>20E. 0B5@V0;: A:;> 1 T<: 2 <; 030;L=0 4>268=0: 360 << &V=0 =09<5=H>W ?>4V;:8: 0,02 <; V4?>2V40T !"# EN ISO 835:2018, I> ?V4B25@46CTBLAO =040=8< C A:;04V B5=45@=>W ?@>?>78FVW !5@B8DV:0B>< O:>ABVHB206V?5B:0 @87=0G5=V 4;O 28<V@N20==O >1 T<C @V48=8 2 ;01>@0B>@=8E C<>20E. 0B5@V0;: A:;> 1 T<: 1 <; 030;L=0 4>268=0: 360 << &V=0 =09<5=H>W ?>4V;:8: 0,01 <; V4?>2V40T !"# EN ISO 835:2018, I> ?V4B25@46CTBLAO =040=8< C A:;04V B5=45@=>W ?@>?>78FVW !5@B8DV:0B>< O:>ABVHB2070B0 100 3 @C;>=0B0 <548G=0 3V3@>A:>?VG=0 3V3VT=VG=0 =5AB5@8;L=0 @C;>= 100 3@0< A:;04  102>2=0 0A<VG5=VABL, % =/1  1,50 >;>3VABL, % =/1  8,0 40B=VABL 4> ?>3;8=0==O, 3, =/<  19 0?V;O@=VABL, <<, =/<  67 !BC?V=L 1V;87=8, % =/< - 66HB\  t v 2 4 6 \`bhȶpYJ;J;J;J;J;hh gCJaJmH sH hh gCJaJmH"sH"-hh gB*CJaJmH"nH phsH"tH %hh gB*CJaJnH phtH hh gCJaJ%hh gB*CJaJmH"phsH" hh ghh g5CJ\aJ"hh g5CJ\aJmH"sH"(hh g5B*CJaJmH"phsH" hh g5B*CJaJph"hd5B*CJaJmH"phsH"Z    * X v $Xdd$If^X`a$$dd$If]a$$dd$If]a$ $]a$gdJ% $]a$gdOp ZZ 2 4 6 qeYJJAA $Ifgd^4$d$Ifa$gd $$Ifa$gd"- $$Ifa$gdd9kd$$Iflrr"%7BnR t(44 la6ytM 6(,.4<JLP<HJN !!>!v!!!!!!!*#,#B#j###$$$$$$ĽĽĽĽĵ׵Ľ׵Ľh*h gCJaJmH"sH"h gCJaJmH"sH"h gCJaJ hh g%hh gB*CJaJmH"phsH"hh gCJaJhh gCJaJmH sH hh gCJaJmH"sH"4 <DJeYYP $Ifgd^4 $$Ifa$gd"-kd:$$Iflrr"%7BnR t(44 la6ytM 6 $$Ifa$gdd9 JLP<DHqeYYPee $Ifgd^4 $$Ifa$gd"- $$Ifa$gdd9kdt$$Iflrr"%7BnR t(44 la6ytM 6HJNjlqeYYPee $Ifgd^4 $$Ifa$gd"- $$Ifa$gdd9kd$$Ifl,rr"%7BnR t(44 la6ytM 6!!!!qeYYPPee $Ifgd^4 $$Ifa$gd"- $$Ifa$gdd9kd$$Iflyrr"%7BnR t(44 la6ytM 6!!!"",#$$$qeee\\ee $Ifgd^4 $$Ifa$gd"-kd"$$Iflrr"%7BnR t(44 la6ytM 6$$$<$$$$%B%%%qee\\\\\\\ $Ifgd $$Ifa$gdM 6kd\$$Ifl5rr"%7BnR t(44 la6ytM 6 $%%&@@@ @2@xAzAAAB BZB\BzB|BBBrCtCCCCCCCJDLDVEXEEE4F6FlFnFFFFFGGJJJJJƽ٪ƽيƛƛƛƛƛƛƛƛƛƽhh gCJaJ hh gB*CJ\aJphhh gB*CJaJph"""%hh gB*CJaJmH"ph"""sH" hh gU%hh gB*CJaJmH"phsH"hh gCJaJmH"sH".hh gB*CJaJfHphq 1%%&@@ @2@zAA\JJ$-DIfM gddkd$$Ifl5rr"%7BnR t(44 la6ytM 6 $$Ifa$gdM 6 $Ifgd 208"5AB =0 203VB=VABL"5AB8 70157?5GCNBL H284:5 O:VA=5 287=0G5==O E>@V>=VG=>3> 3>=04>B@>?V=C 2 A5GV ;N48=8 7 <5B>N 4V03=>AB8:8 203VB=>ABV.030;L=89 B5@<V= ?@840B=>ABV: =5 <5=H5 24 <VA "@820;VABL ?@>2545==O 0=0;V7C  3 E2. 5 ?@89<0B8 4> C2038 @57C;LB0B8 ?VA;O 5 E2. >@>3>289 @V25=L  20 <>/<;. ">G=VABL: 100 % V;L:VABL  1 HB 2 V=482V4C0;L=V9 C?0:>2FV. #?0:>2:0 <VAB8BL B5AB-A<C6:C V ?>3;8=0G 2>;>38, V=AB@C:FVTN C:@0W=AL:>N <>2>N.HB259"5AB =0 B@>?>=V="5AB =0 28O2;5==O "@>?>=V=C , W46-C4P, !1 030;L=89 B5@<V= ?@840B=>ABV 24 <VAOFV @>F54C@0 B5ABC20==O ?@>2>48BLAO ?@8 B5<?5@0BC@V 10  30 !. "5AB-:0A5B0, 7@07>: B0 1CD5@ <0NBL 1CB8 4>2545=V 4> 2:070=>W B5<?5@0BC@8. @07>: 4;O 0=0;V7C: FV;L=0 25=>7=0 :@>2, :0?V;O@=0 :@>2, A8@>20B:0, ?;07<0. B@8<0==O @57C;LB0BV2: 15  30 E2. 'CB;82VABL: =5 =86G5 98,00% !?5F8DVG=VABL: =5 =86G5 100,00% >@>3>289 @V25=L AB0=>28BL: 1,0 =3/<;. 15@V30==O: O: ?@8 :V<=0B=V9 B5<?5@0BC@V, B0: V 2 C<>20E ?>1CB>2>3> E>;>48;L=8:0 (t 2V4 +2 4> +30 !) "5AB  A8AB5<8 <0NBL D>@<0B B5AB  :0A5B8 B0 :>65= B5AB <0T 1CB8 V=482V4C0;L=> C:><?;5:B>20=89 =5>1EV4=8<8 A:;04>28<8 4;O ?@>2545==O B5ABC20==O: >4=>@07>2>N ?V?5B:>N, 1CD5@>< 01> =51C;>N 7 @5035=B>< C :>6=><C B5ABV, A:0@8DV:0B>@>< B0 A?8@B>2>N A5@25B:>N, V=AB@C:FVTN C:@0W=AL:>N <>2>N. HB25 ;O #G0A=8:V2, O:V 1@0B8<CBL CG0ABL C ?@>F54C@V 70:C?V2;V 0<>2=8: 287=0G0T =0ABC?=5: V4?>2V4=VABL B5E=VG=8E E0@0:B5@8AB8: 70?@>?>=>20=>3> #G0A=8:>< ">20@C 28<>30< B5E=VG=>3> 70240==O ?>28==0 1CB8 >1>2 O7:>2> ?V4B25@465=0 =0ABC?=8<8 4>:C<5=B0<8, I> =040NBLAO C A:;04V B5=45@=>W ?@>?>78FVW #G0A=8:0: - :>?VN G8==>W 45:;0@0FVW ?@> 2V4?>2V4=VABL 28<>30< 2V4?>2V4=>3> B5E=VG=>3> @53;0<5=BC I>4> <548G=8E 28@>1V2 B0/01> ?0A?>@B (A5@B8DV:0B) O:>ABV B0 V=AB@C:FVN 7 28:>@8AB0==O (70AB>AC20==O).  <5B>N 70?>1V30==O 70:C?V2;V D0;LA8DV:>20=>W ?@>4C:FVW, I> <>65 =0=5AB8 H:>4C 74>@>2 N ?0FVT=BV2 B0 ?5@A>=0;C, 70157?5G5==O 157?5G=>W @>1>B8 ?5@A>=0;C B0 4>B@8<0==O 70:>=>402AB20 I>4> >E>@>=8 ?@0FV, #G0A=8: ?>28=5= ?V4B25@48B8 <>6;82VABL ?>AB02:8 70?@>?>=>20=>3> =8< ">20@C 2V4?>2V4=>W O:>ABV. 0 ?V4B25@465==O FL>3> #G0A=8: ?>28=5= =040B8 30@0=BV9=89 ;8AB 2V4 28@>1=8:0 (?@54AB02=8FB20, DV;VW 28@>1=8:0  O:I> WE 2V4?>2V4=V ?>2=>2065==O ?>H8@NNBLAO =0 B5@8B>@VN #:@0W=8), 01> ?@54AB02=8:0, 48;5@0, 48AB@81'NB>@0, >DVFV9=> C?>2=>2065=>3> =0 F5 28@>1=8:><, O:8< ?V4B25@46CTBLAO <>6;82VABL ?>AB02:8 #G0A=8:>< B>20@C, O:89 T ?@54<5B>< 70:C?V2;V F8E B>@3V2, 2V4?>2V4=>W O:>ABV, C :V;L:>ABV B0 2 B5@<V=8, 287=0G5=V FVTN 4>:C<5=B0FVTN B0 ?@>?>78FVTN #G0A=8:0.  ;8ABV ?>28==> 1CB8 707=0G5=>: ?>2=5 =09<5=C20==O 0<>2=8:0, =><5@ >3>;>H5==O, I> >?@8;N4=5=5 =0 251-?>@B0;V #?>2=>2065=>3> >@30=C, =0720 ?@54<5B0 70:C?V2;V 2V4?>2V4=> 4> >3>;>H5==O ?@> ?@>2545==O ?@>F54C@8 70:C?V2;V, 0 B0:>6 70?@>?>=>20=89 B>20@ 2 =5>1EV4=V9 :V;L:>ABV. - 0;8H:>289 B5@<V= ?@840B=>ABV B>20@C =0 <><5=B ?>AB0G0==O ?>28=5= A:;040B8 =5 <5=H5 =V6 80% 2V4 7030;L=>3> B5@<V=C WE 715@V30==O, 287=0G5=>3> 28@>1=8:>< 40=>3> B>20@C. #G0A=8: =040T 30@0=BV9=89 ;8AB. - AV 4>:C<5=B8, O:V 28<030NBLAO 0<>2=8:>< 73V4=> F8E B5E=VG=8E 28<>3, <0NBL 1CB8 7020=B065=V #G0A=8:>< 2 A:;04V A2>TW ?@>?>78FVW 4> 7025@H5==O AB@>:C ?>40==O ?@>?>78FV9. # @07V O:I> ?@>?>78FVO =5 2V4?>2V40B8<5 =02545=8< <548:>-B5E=VG=8< 28<>30<, B0:0 ?@>?>78FVO 1C45 2V4E8;5=0 O: B0:0, I> =5 2V4?>2V40T 28<>30< 4>:C<5=B0FVW 40=>W ?@>F54C@8 70:C?V2;V. A B\B|BBtCzCCCCSkd $$Ifl5rr"%7BnR t(44 la6ytM 6 $$Ifa$gdM 6$-DIfM gdd CCCLDXEE6FnFFFGJJ JJ$-DIfM gdd $$Ifa$gdM 6JJJJJrLMUWqeeeYYMM $`a$gdj $`a$gd $^a$gdpkd $$Ifl5rr"%7BnR t(44 la6ytM 6JJrLLLMLMjMnMMMMUVWWXXXʶʶʧkYD(hh g5B*CJaJmH"phsH"#hh g6@CJaJmH"sH"6hX0h gB*CJaJfHmH"phq sH"'hX0h gCJ\aJmH"nH"sH"tH"h gCJaJmH"sH"hX0h gCJaJmH"sH"'h gCJaJfHmH"q sH"-hX0h gCJaJfHmH"q sH"hX0h gCJmH"sH""hh g5>*CJaJmH"sH"WXXXXXZZZ $`a$gd) $`a$gd) $`a$gdjXXZZZ%hh gB*CJaJmH"phsH")hp9h g5@CJ\]aJmH"sH"61hP:pOp. A!"R#7$n% 8$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l, t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V ly t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l5 t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l5 t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l5 t(,5755B5n5R/ / / / / / / / / / a6ytM 68$$If6!vh5755B5n5R#v7#v#vB#vn#vR:V l5 t(,5755B5n5R/ / / / / / / / / / a6ytM 6666666666vvvvvvvvv666666>6666666666666666666666666666666666666666666666666hH66666666666666666666666666666666666666666666666666666666666666666p6J@J J%1KG=K9 CJOJQJ_HaJmHsHtHBA@B A=>2=>9 H@8DB 0170F0Xi@X 01KG=0O B01;8F04 l4a .k. 0 5B A?8A:0 4O4 J%0Iau.iue 7$8$H$"O" 4: docdata,docy,v5,1625,baiaagaaboqcaaadkgqaaawgbaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaadd[$\$O C1760,baiaagaaboqcaaadgquaaaunbqaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa^J-h- " % & ( j k  " $ % ' 5 6     P_o.>k&7W~   bc9tuvw,/00000 0 0 0 0 0 0 000 00 0 0 0 0 00 0 0 0 0 0 00 0 0 0 0 0 00 0 0 0 0 0 00 00 0 0 0 0 00 00 0 0 0 0 0 00000000 0 0 0 0 0 0000000 0 0 0 0 0 00000000000 0 0 0 00000ȑ0ȑ0ȑ0ȑ0ȑ0ȑ0ȑ0ȑ0-/ʑ0ʑ0ȑ0$JXZZ13 JH!$%ACJWZZ./02ZZ_GoBack// ]i ]i ]i ]i ]Ti ]i ]i ]i ]i ]i 9RtY o / >Vy _ u / C *urn:schemas-microsoft-com:office:smarttagsmetricconverter  10 <<100 32 <<360 <<42 <<45 <<55 <<58 <<8 << ProductID                   +,#(-.56;?GMNUekvx!,.68?DPR^bku{}%'./7@GHPX^_glr{ ,:=HNPQVWbdl},23ABJX^_ijpq{  '+57<BMNQ^hlu#'129<GIQRUgkqx ( 2 8 > w     " ( * / 0 3 B G \ e z    ' 3 7 C D R _ j k r s y |     " # ) , 4 6 : ; @ G O P W ` d e n o v     " # ) , 8 9 ? B J L P Q V ] e f m v z { o{EQR_&)*,LNW`wyz|NY/-89uwNOVZ ! " $ & i   . / F G  ! " $ % ' s t  ` a # $ v w   OP^_n-.=>jk%&67VW}~ ac89sw+/. (  6   //+MWMW#MWMWMW#MW MW#MW MW MW MW MWMW#MWMWMWMWMWMWMWMWMWMW#MWMWMW#MWMWMWMW#MWMWMWMWMWMW#MW MW!MWMW"MW#MW$MW#MW%MWMW&MW#MW'MWMW(MW)MW#MW*MW+MWMW,MW#MW-MW.MW#MW/MWMW="-  4: njtBJ%}%@&)n*=+C-V2 W3^4M 6&y7d9@ @2DbJ`MARaR gmpE[r7t&M{dpS{4WlJZ: , HYU*dCX0_%RS@xELcOpp9E- " % & ( k  " $ % ' 6       /@,,XP,,( -@@"@@UnknownG>[x Times New Roman5Symbol3& >[x Arial7&>{$ Calibri"Ah4gy#ʑ'/4343724HP)$PJ%2AdminMicrosoft OfficeOh+'0  8 D P \hpxAdminNormalMicrosoft Office47Microsoft Office Word@84#@j@@l3@d4՜.+,0 hp|  3'     !"#$%&'()*+,-./012346789:;<>?@ABCDEFGHIJKLMNOPQRSTUVWYZ[\]^_abcdefgjRoot Entry F }lData 51Table=]4WordDocument8hSummaryInformation(XDocumentSummaryInformation8`CompObjq  F Microsoft Office Word MSWordDocWord.Document.89q