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?@>F54C@8 70:C?V2;V, ?5@51C20T 2 707=0G5=8E >1AB028=0E, 2V= <>65 =040B8 ?V4B25@465==O 268BBO 70E>4V2 4;O 4>2545==O A2>TW =04V9=>ABV, =572060NG8 =0 =0O2=VABL 2V4?>2V4=>W ?V4AB028 4;O 2V4<>28 2 CG0ABV C 2V4:@8B8E B>@30E. ;O FL>3> ?5@5<>65FL ?>28=5= 4>25AB8, I> 2V= A?;0B82 01> 7>1>2 O702AO A?;0B8B8 2V4?>2V4=V 7>1>2 O70==O B0 2V4H:>4C20==O 70240=8E 718B:V2.  >40B>: !3 4> B5=45@=>W 4>:C<5=B0FVW "5E=VG=V, O:VA=V, :V;L:VA=V E0@0:B5@8AB8:8 ?@54<5B0 70:C?V2;V -"%'  =0 70:C?V2;N ?> ?@54<5BC 70:C?V2;V  021:2015: 33690000-3 - V:0@AL:V 70A>18 @V7=V (53599 ;L1C<V= IVD, @5035=B 52929 030;L=0 ;C6=0 D>AD0B070 (ALP) IVD, @5035=B 52925 ;0=V=0<V=>B@0=AD5@070 (ALT) IVD, @5035=B 52941 030;L=0 0<V;070 IVD, @5035=B 52955 030;L=0 0A?0@B0B0<V=>B@0=AD5@070 (AST) IVD, @5035=B 53231 030;L=89 1V;V@C1V= IVD, @5035=B 52981 V1C:0V=>2>5 G8A;> E>;V=5AB5@078 (2V4A>B>: V=3V1C20==O) IVD, @5035=B 53362 030;L=89 E>;5AB5@8= IVD, @5035=B 53252 @50B8=V= IVD, @5035=B 53707 C-@50:B82=89 1V;>: (! ) IVD, @5035=B 60774 V>:A84 2C3;5FN (CO2) , @5035=B 53030 0<0-3;CB0<V;B@0=AD5@070 (") IVD, @5035=B 53307 ;N:>70 IVD, @5035=B 53989 030;L=89 1V;>: IVD, @5035=B 53231 030;L=89 1V;V@C1V= IVD, @5035=B 53989 030;L=89 1V;>: IVD, @5035=B 53462 "@83;VF5@848 IVD, @5035=B 53989 030;L=89 1V;>: IVD, @5035=B 53590 !5G>28=0 (Urea) IVD, @5035=B 53586 !5G>20 :8A;>B0 IVD, @5035=B 59090 ;V:>78;L>20=89 35<>3;>1V= (HbA1c) , =01V@, 5D5;><5B@8G=89 / BC@1848<5B@8G=8< 0=0;V7 53758 030;L=89 V<C=>3;>1C;V=  (IgA) IVD, =01V@, =5D5;><5B@8G=89 / BC@1V48<5B@8G=89 0=0;V7 53785 030;L=89 V<C=>3;>1C;V= G (7030;L=89 IgG) IVD, :><?;5:B, =5D5;><5B@VO / BC@1V48<5B@VO 53793 030;L=89 V<C=>3;>1C;V=  (7030;L=89 IgM) IVD, :><?;5:B, =5D5;><5B@VO/BC@1V48<5B@VO 48304 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> O45@=>3> 0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V7 48348 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> 5-0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V7 48316 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> >1>;>=:8 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(4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V7 48331 V@CA 35?0B8BC B, e 0=B835=8 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB 48321 V@CA 35?0B8BC B, ?>25@E=5289 0=B835= IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB 48446 -1/-2, 0=B835=8/0=B8BV;0 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V7 60922 '8A;5==V D>@<8 25- 3V4@>:A82VB0<V=C D IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V7 - 47869 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :>=B@>;L=89 <0B5@V0; 47869 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :>=B@>;L=89 <0B5@V0; 53987 030;L=89 1V;>: VD, :>=B@>;L=89 <0B5@V0; 53987 030;L=89 1V;>: VD, :>=B@>;L=89 <0B5@V0; 41838 !-@50:B82=89 1V;>: (CRP) IVD, :0;V1@0B>@ 41838 !-@50:B82=89 1V;>: (CRP) IVD, :0;V1@0B>@ 47869 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :>=B@>;L=89 <0B5@V0; 47869 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :>=B@>;L=89 <0B5@V0; 44435 >=B@>;L=89 <0B5@V0; 4;O 287=0G5==O 3;V:>20=>3> 35<>3;>1V=C (HbA1c), IVD 44435 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28<V@C-BL548:>- B5E=VG=V 28<>38:>4 1V>EV<VG=V 28@>18 " ! ;L1C<V= (ALB), @5035=B =0 =>AVW (C?0:>2:0 7 5 :0@B@846V2 ?> 18 A;094V2, 90 A;094V2)?0:>25 5G>28=0 01> @50:B82, O:89 70AB>A>2CNBL A?V;L=> 7 ?>G0B:>28< 28@>1>< 4;O IVD ,I>1 28:>=C20B8 >A>1;82C DC=:FVN 2 0=0;V7C20==V B0 :V;L:VA=> 287=0G8B8 0;L1C<V= (albumin) C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53599 ;L1C<V= IVD, @5035=B2V>EV<VG=V 28@>18 " ! C6=0 D>AD0B070 (ALKP), @5035=B =0 =>AVW (5 :0@B@846V2 ?> 60 A;094V2, 300 A;094V2)/VITROS Chemistry Products ALKP Slides?0:>23 5G>28=0 01> @50:B82, O:89 70AB>A>2CNBL A?V;L=> 7 ?>G0B:>28< 28@>1>< 4;O IVD ,I>1 28:>=C20B8 >A>1;82C DC=:FVN 2 0=0;V7C20==V B0 :V;L:VA=> 287=0G8B8 7030;L=C ;C6=C D>AD0B07C ($) (alkaline phosphatase (ALP)) C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().52929 030;L=0 ;C6=0 D>AD0B070 (ALP) IVD, @5035=B3V>EV<VG=V 28@>18 " ! ;0=V=0<V=>B@0=AD5@070 (ALTV), @5035=B =0 =>AVW (5 :0@B@846V2 ?> 60 A;094V2, 300 A;094V2)?0:>215 5035=B8, ?@87=0G5=V 4;O :V;L:VA=>3> 28<V@N20==O 0:B82=>ABV 0;0=V=0<V=>B@0=AD5@078 C A8@>20BFV B0 ?;07<V. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().52925 ;0=V=0<V=>B@0=AD5@070 (ALT) IVD, @5035=B4V>EV<VG=V 28@>18 " ! <V;070 (AMYL), @5035=B =0 =>AVW (5 :0@B@846V2 ?> 18 A;094V2, 90 A;094V2)?0:>22 5G>28=0 01> @50:B82, O:89 70AB>A>2CNBL A?V;L=> 7 ?>G0B:>28< 28@>1>< 4;O IVD ,I>1 28:>=C20B8 >A>1;82C DC=:FVN 2 0=0;V7C20==V B0 :V;L:VA=> 287=0G8B8 7030;L=C 0<V;07C () (total amylase) 2 :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().52941 030;L=0 0<V;070 IVD, @5035=B5V>EV<VG=V 28@>18 " ! 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E!2, @5035=B =0 =>AVW (5 :0@B@846V2 ?> 60 A;094V2, 300 A;094V2)?0:>22 5G>28=0 01> @5035=B, ?@87=0G5=89 4;O 28:>@8AB0==O A?V;L=> 7 28EV4=8< 28@>1>< 4;O  7 <5B>N 28:>=0==O ?52=>W DC=:FVW 2 0=0;V7V, O:89 28:>@8AB>2CTBLAO ?@8 :V;L:VA=><C 287=0G5==V 2<VABC 4V>:A84C 2C3;5FN (carbon dioxide, CO2) 2 :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().60774 V>:A84 2C3;5FN (CO2) , @5035=B12V>EV<VG=V 28@>18 " ! 0<0-3;CB0<V;B@0=AD5@070 (GGT), @5035=B =0 =>AVW (5 :0@B@846V2 ?> 50 A;094V2, 250 A;094V2)?0:>22 5G>28=0 01> @50:B82, O:89 70AB>A>2CNBL A?V;L=> 7 ?>G0B:>28< 28@>1>< 4;O IVD ,I>1 28:>=C20B8 >A>1;82C DC=:FVN 2 0=0;V7C20==V B0 :V;L:VA=> 287=0G8B8 30<0-3;CB0<V;B@0=AD5@07C (") (gamma glutamyltransferase (GGT)) C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53030 0<0-3;CB0<V;B@0=AD5@070 (") IVD, @5035=B13V>EV<VG=V 28@>18 " ! ;N:>70 (GLU), @5035=B =0 =>AVW (5 :0@B@846V2 ?> 60 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;V:>78;L>20=89 35<>3;>1V=, =01V@ @5035=BV2 (HbA1c)/VITROS Chemistry Products HbA1c Reagent Kit?0:>2201V@ @5035=BV2 B0 V=H8E ?>2'O70=8E 7 =8<8 <0B5@V0;V2, ?@87=0G5=89 4;O O:VA=>3> B0 / 01> :V;L:VA=>3> 287=0G5==O 3;V:>78;L>20=>3> 35<>3;>1V=C (glycated haemoglobin (HbA1c)), B0:>6 2V4><>3> O: 3;V:>78;L>20=89 35<>3;>1V= (glycosylated haemoglobin), 2 :;V=VG=><C 7@07:C <5B>4>< =5D5;><5B@8G=>3> / BC@1848<5B@8G=8< 0=0;V7C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().59090 ;V:>78;L>20=89 35<>3;>1V= (HbA1c) , =01V@, 5D5;><5B@8G=89 / BC@1848<5B@8G=8< 0=0;V722V>EV<VG=V 28@>18 " ! <C=>3;>1C;V=8 , @5035=B (IgA)/ VITROS Chemistry Products IgA Reagent?0:>2201V@ @5035=BV2 B0 AC?CB=VE <0B5@V0;V2, O:8<8 O:VA=> B0 / 01> :V;L:VA=> 287=0G0NBL 7030;L=89 V<C=>3;>1C;V= A (total immunoglobulin A (IgA total)) 2 :;V=VG=><C 7@07:C <5B>4>< =5D5;><5B@8G=>3> / BC@1V48<5B@8G=>3> 0=0;V7C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53758 030;L=89 V<C=>3;>1C;V=  (IgA) IVD, =01V@, =5D5;><5B@8G=89 / BC@1V48<5B@8G=89 0=0;V723V>EV<VG=V 28@>18 " ! <C=>3;>1C;V=8 G, @5035=B (IgG)/VITROS Chemistry Products IgG Reagent?0:>22 5035=B8 V AC?CB=V <0B5@V0;8, O:8<8 O:VA=> B0 / 01> :V;L:VA=> 287=0G0NBL 7030;L=89 V<C=>3;>1C;V= G (7030;L=C :V;L:VABL IgG) C :;V=VG=><C 7@07:C <5B>4>< =5D5;><5B@VW / BC@1V48<5B@VW. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53785 030;L=89 V<C=>3;>1C;V= G (7030;L=89 IgG) IVD, :><?;5:B, =5D5;><5B@VO / BC@1V48<5B@VO24V>EV<VG=V 28@>18 " ! <C=>3;>1C;V=8 , @5035=B (IgM)/VITROS Chemistry Products IgM Reagent?0:>22 5035=B8 V AC?CB=V <0B5@V0;8, O:8<8 O:VA=> B0 / 01> :V;L:VA=> 287=0G0NBL 7030;L=89 V<C=>3;>1C;V=  (7030;L=C :V;L:VABL IgM) C :;V=VG=><C 7@07:C <5B>4>< =5D5;><5B@VW / BC@1V48<5B@VW. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53793 030;L=89 V<C=>3;>1C;V=  (7030;L=89 IgM) IVD, :><?;5:B, =5D5;><5B@VO/BC@1V48<5B@VO25<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O 7030;L=8E 0=B8BV; 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBc Reagent Pack?0:>21;O O:VA=>3> 287=0G5==O 0=B8BV; 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC  (0=B8-HBA). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48304 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> O45@=>3> 0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V726<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O 0=B8BV; 4> 0=B835=C  2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBe Reagent Pack?0:>21;O O:VA=>3> 287=0G5==O 0=B8BV; 4> 0=B835=C  2V@CAC 35?0B8BC  (0=B8-HBe). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48348 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> 5-0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V727<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O 0=B8BV; 4> ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBs Reagent Pack?0:>21;O :V;L:VA=>3> 287=0G5==O 0=B8BV; 4> ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC  (0=B8-HBs). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48316 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> >1>;>=:8 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB28<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O 0=B8BV; 4> 2V@CAC 35?0B8BC !/VITROS Immunodiagnostic Products Anti-HCV Reagent Pack?0:>23;O O:VA=>3> 287=0G5==O 0=B8BV; 4> 2V@CAC 35?0B8BC C (0=B8-HCV). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48366 V@CA 35?0B8BC C, 7030;L=V 0=B8BV;0 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V729<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O D5@8B8=C /VITROS Immunodiagnostic Products Ferritin Reagent Pack?0:>21 5035=B 4;O :V;L:VA=>3> 287=0G5==O D5@8B8=C 2 A8@>20BFV B0 ?;07<V ;N48=8 (35?0@8=) 7 28:>@8AB0==O< V<C=>4V03=>AB8G=8E B0 V=B53@>20=8E A8AB5< " !. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().61078 $5@@8B8= IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V730<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O V<C=>3;>1C;V=V2 :;0AC  (IgM) 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack?0:>21;O O:VA=>3> 287=0G5==O 0=B8BV; IgM 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC  (HBc). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48298 V@CA 35?0B8BC B, 0=B8BV;0 :;0AC V<C=>3;>1C;V=  (Ig) 4> O45@=>3> 0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V731<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O 0=B835=C  2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products HBeAg Reagent Pack?0:>21;O O:VA=>3> 287=0G5==O 0=B835=C  2V@CAC 35?0B8BC  (HBeAg). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48331 V@CA 35?0B8BC B, e 0=B835=8 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB32<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC , ?V428I5=0 GCB;82VABL/VITROS Immunodiagnostic Products HBsAg ES Reagent Pack?0:>23;O O:VA=>3> 287=0G5==O ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC . 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48321 V@CA 35?0B8BC B, ?>25@E=5289 0=B835= IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB33<C=>4V03=>AB8G=V 28@>18 " ! ><1> 5035=B 4;O 287=0G5==O 0=B8BV; 4> 2V@CAC V<C=>45DVF8BC ;N48=8 ?0:>22;O >4=>G0A=>3> O:VA=>3> 287=0G5==O 0=B8BV; 4> 2V@CAC V<C=>45DVF8BC ;N48=8 B8?C 1, 2:;NG0NG8 3@C?C , B0/01> 2 (0=B8-HIV-1 B0 0=B8-HIV-2) B0 0=B835=C HIV @24. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48446 -1/-2, 0=B835=8/0=B8BV;0 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V734<C=>4V03=>AB8G=V 28@>18 " ! 5035=B 4;O 287=0G5==O 25-OH 2VB0<V=C D 7030;L=>3>?0:>21 5035=B 4;O :V;L:VA=>3> 287=0G5==O 25-OH 2VB0<V=C D 7030;L=>3> 2 A8@>20BFV :@>2V ;N48=8 7 28:>@8AB0==O< V<C=>4V03=>AB8G=8E A8AB5< B0 V=B53@>20=8E A8AB5< " !. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().60922 '8A;5==V D>@<8 25- 3V4@>:A82VB0<V=C D IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V735V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 1/ VITROS Chemistry Products Calibrator Kit 1?0:>240B5@V0;, I> 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V <=>68==8E 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47868 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :0;V1@0B>@36V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 2/ VITROS Chemistry Products Calibrator Kit 2?0:>240B5@V0;, I> 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V <=>68==8E 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47868 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :0;V1@0B>@37V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 3 /VITROS Chemistry Products Calibrator Kit 3?0:>230B5@V0;, O:8< CAB0=>2;NNBL @5D5@5=B=V 7=0G5==O 4;O 0=0;V7C20==O, I>1 :V;L:VA=> 287=0G0B8 >48= 01> :V;L:0 D5@<5=BV2 :;V=VG=>W EV<VW (multiple clinical chemistry enzyme) C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().52903 =>68==V D5@<5=B8 :;V=VG=>W EV<VW IVD, :0;V1@0B>@38V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 4 / VITROS Chemistry Products Calibrator Kit 4?0:>230B5@V0;, I> 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V <=>68==8E 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47868 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :0;V1@0B>@39V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 5 /VITROS Chemistry Products Calibrator Kit 5?0:>210B5@V0;, I> 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V <=>68==8E 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47868 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :0;V1@0B>@40V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 6 /VITROS Chemistry Products Calibrator Kit 6?0:>210B5@V0;, I> 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V <=>68==8E 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47868 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :0;V1@0B>@41V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 7/VITROS Chemistry Products Calibrator Kit 7?0:>240B5@V0;, O:89 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=>3> 4;O :V;L:VA=>3> 28<V@N20==O !-@50:B82=>3> 1V;:0 (!R ) C :;V=VG=V9 ?@>1V. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().41838 !-@50:B82=89 1V;>: (CRP) IVD, :0;V1@0B>@42V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 10/VITROS Chemistry Products Calibrator Kit 10?0:>220B5@V0;, I> 2AB0=>2;NT @5D5@5=B=V 7=0G5==O 4;O 0=0;V7C20==O :V;L:VA=>3> 287=0G5==O 7030;L=>3> 1V;:0 C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53988 030;L=89 1V;>: IVD, :0;V1@0B>@43V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 20/ VITROS Chemistry Products Calibrator Kit 20?0:>220B5@V0;, O:89 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=>3> 4;O 28:>@8AB0==O 4;O :V;L:VA=>3> 28<V@N20==O B@0=AD5@8=C 2 :;V=VG=><C 4>A;V465==V. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().41343 "@0=AD5@8= IVD, :0;V1@0B>@44V>EV<VG=V 28@>18 " ! 01V@ :0;V1@0B>@V2 31/VITROS Chemistry Products Calibrator Kit 31?0:>210B5@V0;, O:8< CAB0=>2;NNBL @5D5@5=B=V 7=0G5==O 4;O 0=0;V7C20==O, I>1 O:VA=> B0 / 01> :V;L:VA=> 287=0G0B8 3;V:>78;L>20=89 35<>3;>1V= (glycated haemoglobin (HbA1c)), B0:>6 2V4><89 O: 3;V:>78;L>20=89 35<>3;>1V= (glycosylated haemoglobin) C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53315 ;V:>78;L>20=89 35<>3;>1V= (HbA1c) IVD, :0;V1@0B>@45V>EV<VG=V 28@>18 " ! 01V@ FS :0;V1@0B>@V2 1/VITROS Chemistry Products FS Calibrator 1?0:>210B5@V0;, I> 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V <=>68==8E 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47868 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :0;V1@0B>@46<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@ 4;O 287=0G5==O 7030;L=8E 0=B8BV; 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBc Calibrator?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< 4;O O:VA=>3> 287=0G5==O 0=B8BV; 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC  (0=B8-HBA). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48304 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> O45@=>3> 0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V747<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@ 4;O 287=0G5==O V<C=>3;>1C;V=V2 :;0AC  (IgM) 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< 4;O O:VA=>3> 287=0G5==O V<C=>3;>1C;V=V2 :;0AC  (IgM) 4> O45@=>3> 0=B835=C 2V@CAC 35?0B8BC  (HBc). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48298 V@CA 35?0B8BC B, 0=B8BV;0 :;0AC V<C=>3;>1C;V=  (Ig) 4> O45@=>3> 0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V748<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@ 4;O 287=0G5==O 0=B8BV; 4> 0=B835=C  2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBe Calibrator?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< 4;O O:VA=>3> 287=0G5==O 0=B8BV; 4> 0=B835=C  2V@CAC 35?0B8BC  (0=B8-HBe). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48348 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> 5-0=B835=C IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V749<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@8 4;O 287=0G5==O 0=B8BV; 4> ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products Anti-HBs Calibrators?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< 4;O :V;L:VA=>3> 287=0G5==O 0=B8BV; 4> ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC  (0=B8-HBs). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48316 V@CA 35?0B8BC B, 7030;L=V 0=B8BV;0 4> >1>;>=:8 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB50<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@ 4;O 287=0G5==O 0=B8BV; 4> 2V@CAC 35?0B8BC !/VITROS Immunodiagnostic Products Anti-HCV Calibrator?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< 4;O O:VA=>3> 287=0G5==O 0=B8BV; 4> 2V@CAC 35?0B8BC C (0=B8-HCV). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48366 V@CA 35?0B8BC C, 7030;L=V 0=B8BV;0 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V751<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@8 4;O 287=0G5==O D5@8B8=C/VITROS Immunodiagnostic Products Ferritin Calibrators?0:>210;V1@0B>@8 4;O 70AB>AC20==O 4;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< B0 V=B53@>20=8E A8AB5< " ! 4;O :V;L:VA=>3> 287=0G5==O D5@8B8=C 2 A8@>20BFV B0 ?;07<V ;N48=8 (35?0@8=). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().61078 $5@@8B8= IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V752<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@ 4;O 287=0G5==O 0=B835=C  2V@CAC 35?0B8BC /VITROS Immunodiagnostic Products HBeAg Calibrator?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< 4;O O:VA=>3> 287=0G5==O 0=B835=C  2V@CAC 35?0B8BC . 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48331 V@CA 35?0B8BC B, e 0=B835=8 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB53<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@ 4;O 287=0G5==O ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC , ?V428I5=0 GCB;82VABL/VITROS Immunodiagnostic Products HBsAg ES Calibrator?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< 4;O O:VA=>3> 287=0G5==O ?>25@E=52>3> 0=B835=C 2V@CAC 35?0B8BC  (HBsAg). 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48321 V@CA 35?0B8BC B, ?>25@E=5289 0=B835= IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E@><0B>3@0DVG=89 B5AB54<C=>4V03=>AB8G=V 28@>18 " ! ><1> 0;V1@0B>@ 4;O 287=0G5==O 0=B8BV; 4> 2V@CAC V<C=>45DVF8BC ;N48=8 ?0:>21;O :0;V1@C20==O V<C=>4V03=>AB8G=8E A8AB5< ?@8 O:VA=><C 287=0G5==V 0=B8BV; 4> 2V@CAC V<C=>45DVF8BC ;N48=8 B8?C 1, 2:;NG0NG8 3@C?C , B0/01> 2 (Anti-HIV-1 B0 Anti-HIV-2) B0 0=B835=C HIV @24. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().48446 -1/-2, 0=B835=8/0=B8BV;0 IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V755<C=>4V03=>AB8G=V 28@>18 " ! 0;V1@0B>@8 4;O 287=0G5==O 25-OH 2VB0<V=C D 7030;L=>3>?0:>210;V1@0B>@8 4;O 70AB>AC20==O 4;O :0;V1@C20==O <C=>4V03=>AB8G=8E A8AB5< " ! B0 V=B53@>20=8E A8AB5< 4;O :V;L:VA=>3> 287=0G5==O 25-OH 2VB0<V=C D 7030;L=>3> 2 A8@>20BFV :@>2V ;N48=8. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().60922 '8A;5==V D>@<8 25- 3V4@>:A82VB0<V=C D IVD (4V03=>AB8:0 in vitro), =01V@, V<C=>E5<V;N<V=5AF5=B=89 0=0;V756 V48=8 4;O ?5@52V@:8 <V:@>A5=A>@0 I V II /MicroSensor Check Fluids I & II?0:>21 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().-57V>EV<VG=V 28@>18 " ! >=B@>;L=89 7@07>: I / VITROS Chemistry Products Performance Verifier I?0:>250B5@V0;, O:89 28:>@8AB>2CTBLAO 4;O ?V4B25@465==O O:>ABV 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V >4=>3> 01> 157;VGV 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47869 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :>=B@>;L=89 <0B5@V0;58V>EV<VG=V 28@>18 " ! >=B@>;L=89 7@07>: II /VITROS Chemistry Products Performance Verifier II?0:>250B5@V0;, O:89 28:>@8AB>2CTBLAO 4;O ?V4B25@465==O O:>ABV 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V >4=>3> 01> 157;VGV 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47869 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :>=B@>;L=89 <0B5@V0;59V>EV<VG=V 28@>18 " ! >=B@>;L=89 7@07>:  4;O 287=0G5==O 1V;:0 C A5GV (UPRO)/VITROS Chemistry Products UPRO Peformance Verifier I?0:>220B5@V0; 4;O ?5@52V@O==O O:>ABV 0=0;V7C :V;L:VA=>3> 287=0G5==O 7030;L=>3> 1V;:0 C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53987 030;L=89 1V;>: VD, :>=B@>;L=89 <0B5@V0;60V>EV<VG=V 28@>18 " ! >=B@>;L=89 7@07>:  4;O 287=0G5==O 1V;:0 C A5GV (UPRO)/VITROS Chemistry Products UPRO Peformance Verifier II?0:>220B5@V0; 4;O ?5@52V@O==O O:>ABV 0=0;V7C :V;L:VA=>3> 287=0G5==O 7030;L=>3> 1V;:0 C :;V=VG=><C 7@07:C. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().53987 030;L=89 1V;>: VD, :>=B@>;L=89 <0B5@V0;61V>EV<VG=V 28@>18 " ! >=B@>;L=89 7@07>:  4;O 287=0G5==O !-@50:B82=>3> 1V;:0 (CRP)/VITROS Chemistry Products CRP Performance Verifier I?0:>230B5@V0;, O:89 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=>3> 4;O :V;L:VA=>3> 28<V@N20==O !-@50:B82=>3> 1V;:0 (!R ) C :;V=VG=V9 ?@>1V. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().41838 !-@50:B82=89 1V;>: (CRP) IVD, :0;V1@0B>@62V>EV<VG=V 28@>18 " ! >=B@>;L=89 7@07>:  4;O 287=0G5==O !-@50:B82=>3> 1V;:0 (CRP)/VITROS Chemistry Products CRP Performance Verifier II?0:>230B5@V0;, O:89 28:>@8AB>2CTBLAO 4;O 2AB0=>2;5==O @5D5@5=B=8E 7=0G5=L 4;O 0=0;V7C, ?@87=0G5=>3> 4;O :V;L:VA=>3> 28<V@N20==O !-@50:B82=>3> 1V;:0 (!R ) C :;V=VG=V9 ?@>1V. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().41838 !-@50:B82=89 1V;>: (CRP) IVD, :0;V1@0B>@63V>EV<VG=V 28@>18 " ! V4:89 :>=B@>;L=89 7@07>: I/VITROS Chemistry Products Liquid Performance Verifier I?0:>240B5@V0;, O:89 28:>@8AB>2CTBLAO 4;O ?V4B25@465==O O:>ABV 0=0;V7C, ?@87=0G5=89 4;O 28:>@8AB0==O ?@8 O:VA=><C V / 01> :V;L:VA=><C 287=0G5==V >4=>3> 01> 157;VGV 0=0;VBV2 :;V=VG=>W EV<VW (multiple clinical chemistry analytes), O:V A?V;L=> CB2>@NNBL ?>2=>FV==89 1V>EV<VG=89 ?@>DV;L. 5035=B ?>28=5= 1CB8 AC<VAB=89 7 0=0;V70B>@0<8 Vitros 5600 (Ortho Clinical Diagnostic, !().47869 =>68==V 0=0;VB8 :;V=VG=>W EV<VW IVD, :>=B@>;L=89 <0B5@V0;64V>EV<VG=V 28@>18 " ! 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