List of NGSP Certified Methods (updated 10/15, listed by date certified)
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- Norah Jones
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1 Lis of NGSP Cerified Mehods (updaed 10/15, lised by dae cerified) The NGSP has cerified he following mehods and reagens as having documened raceabiliy o he Diabees Conrol and Complicaions Trial Mehod. Manufacurers are awarded Cerificaes of Traceabiliy for successfully compleing bias esing for specific mehods, reagen los, calibraor los and insrumenaion used. Traceabiliy o he DCCT applies only o resuls from fresh blood samples. Analysis of processed (e.g. lyophilized) maerial may be subjec o marix effecs and any comparisons o he DCCT using resuls from processed specimens should be made wih cauion. The NGSP recommends ha manufacurers cerify heir mehods each year; he cerificae of raceabiliy expires afer 1 year. During he year i is he responsibiliy of he manufacurer o insure ha he resuls of heir mehod remain consisen over ime hroughou he year and beween los. I is no he inen of he NGSP o cerify each lo of reagens. Manufacurer ROHM Co., Ld. Axis-Shield Archem Diagnosic Indusry Ld. Arkray, Inc. Hiachi Chemical Co., Ld. HORIBA Medical Mehod/ Insrumen Direc Mehod (2 Reagens) Immuno-assay ADAMS A1c Lie HA- 8380V Varian mode ADAMS A1c Lie HA- 8380V Fas mode ADAMS A1c Lie HA-8380 Seraesum A1C WB Whole Blood Penra C400 Y=(0.42*X)+2.25 Mehod Type Spochem Banalys on SI Axis-Shield ki on AU400 Dae Cerified Oc 15 Reagen Lo 1533FD07 7O Calibraor Lo Oc Calibraor Assigned WC , 24.0, 51.0, 82.8, mmol/mol 0.00%, 4.40%, 7.00%, 9.90%, 13.30% Oc 15 AR %, 9.05%, 11.9%, 16.02% Oc 15 5E1012, 5E1021, 4L1401, 4J1053 Oc 15 5E1012, 5E1021, 4L1401, 4J1053 Oc 15 5E1012, 5E1021, 4J1053 Column Lo Laboraory ESRL#12 S %, 10.5% 4J101U S %, 10.5% 4J101U S %, 10.5% 4J206N Enzymaic Oc 15 Y5C Oc , 1.60, 2.90, 4.20, 7.00, µmol/l ; µmol/l 1
2 Manufacurer HORIBA Medical Green Cross Medis Corp. SD Biosensor, Inc. Mindray Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo WB Hemolysae Penra C400 Y=(0.43*X)+2.06 WB Hemolysae Penra C200 Y=(0.35*X)+2.24 WB Whole Blood ABX Penra 400 Y=(0.43*X)+2.14 WB Hemolysae Penra 400 Y=(0.43*X)+1.98 Boronae Affiniy (LabonaCheck A1c Analyzer, A1Card Analyzer SD A1cCare Sysem Enzymaic on BS-200E Enzymaic on BS-380 Enzymaic on BS-400 Boronae affiniy Oc , 1.60, 2.90, 4.20, 7.00, µmol/l ; µmol/l Oc , 1.60, 2.90, 4.20, 7.00, µmol/l ; µmol/l Oc , 1.60, 2.90, 4.20, 7.00, µmol/l ; µmol/l Oc , 1.60, 2.90, 4.20, 7.00, µmol/l ; µmol/l Sep 15 H05G2901, H05G2902, HM236GH UEW Laboraory - - Sep 15 A1C Enzymaic Sep , ; 91.54, Enzymaic Sep , ; 91.54, Enzymaic Sep , ; 91.54,
3 Manufacurer Mindray Quoien Diagnosics Limied Beckman Couler Ireland Inc. Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo Enzymaic on BS-480 Enzymaic on BS-800/800M Enzymaic on BS- 2000/2000M Quo-Tes on Quo-Tes Quo-Lab on Quo-Lab B00389 Applicaion AU5800 B00389 Applicaion AU2700 B00389 Applicaion AU640 B00389 Applicaion AU680 B00389 Applicaion AU480 Enzymaic Sep , ; 91.54, Enzymaic Sep , ; 91.54, Enzymaic Sep , ; 91.54, Boronae affiniy Boronae affiniy Laboraory Sep ESRL #11 Sep ESRL #11 Sep , M Sep , M Sep , M Sep , M Sep , M , 0.278, 0.515, 0.892, ; 8.69 T , 0.278, 0.515, 0.892, ; 8.69 T , 0.278, 0.515, 0.892, ; 8.69 T , 0.278, 0.515, 0.892, ; 8.69 T , 0.278, 0.515, 0.892, ; 8.69 T E E E E E 3
4 Manufacurer Beckman Couler Ireland Inc. Orho Clinical Diagnosics Kyowa Medex Co., Ld. JEOL Ld. Beckman Couler, Inc. Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo B00389 Applicaion AU400 %A1c on Viros 5,1 FS %A1c on Viros 4600 %A1c on Viros 5600 MeaboLead on JCA- BM9130 MeaboLead on DM- JACK MeaboLead on Hiachi-7180 MeaboLead on TBA- 120FR BM Tes on JCA- BM 6010/C HBA1c on UniCel DxC 800 Sep , M , 0.278, 0.515, 0.892, ; 8.69 T Sep , 0.922, 1.886, g/dl ; , 3.692, 8.200, g/dl Sep , 0.927, 1.889, g/dl ; , 3.692, 8.200, g/dl Sep , 0.927, 1.889, g/dl ; , 3.692, 8.200, g/dl Enzymaic Sep AEE, 131AEE Enzymaic Sep AEE, 131AEE Enzymaic Sep AEE, 131AEE Enzymaic Sep AEE, 131AEE Enzymaic Sep RHL, 816RHL, 816RLL Sep 15 M505354, M406277, M506571, M AEE 2.33, 9.38 ; 82.8, AEE 2.33, 9.38 ; 82.8, AEE 2.33, 9.38 ; 82.8, AEE 2.33, 9.38 ; 82.8, RIL 3.28, 15.53, 92.9, M , 0.451, 0.853, 1.582, g/dl ; g/dl Laboraory E 4
5 Manufacurer Agappe Diagnosics Ld. Careium Medical Insrumens Co., Limied Guangzhou Wondfo Bioech Co., Ld. A.Menarini Diagnosics Samsung Elecronics GuangDong Uniy Bioechnology Co., Ld. Zivak Technologies Jiangsu Audicom Medical Technology Co., Ld. Sakae Corporaion Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo Immuno assay on AGA1C Immuno assay on Mispa i2 Immuno assay on Mispa i3 Auo A1c HA-8180V ADAMS Auo A1c HA-8160 ADAMS Auo A1c on Premier on LabGEO PT10 Boronic Affiniy Chromaography on ki on Analyzer Ion-exchange, AC6601 Analyzer Medidas on A1c GEAR Medidas on A1c igear Caion-exchange Chromaography on Analyzer KH- 101 Fluorescence immunoassay on Finecare FIA Meer Boronae affiniy Boronae affiniy Sep , , Sep , , Sep , , , , , , , , , , , Aug A, A 4.70%, 7.60%, 12.00%, 15.70% 4.70%, 7.60%, 12.00%, 15.70% 4.70%, 7.60%, 12.00%, 15.70% Laboraory 5.2%, 11.10% S ReCCS Aug 15 F207F602A - - July 15 5A1201, 4J1211, 4J1501, 5A1221 July , , , July , 5162, 5305, 4907 Q00CAG4N JCCRM R , R , R HB-1501, HB , , , , %, 10.70% %, 10.70% 5211, %, 11.40% 5.0%, 5.6%, 7.3%, 9.4%, 12.0% 3F014Q 4J0354 European European European HC14101N 6.0%, 12.5% HC14101N HB % HB-1501 European , STS %, 5.0%, 9.2%, 12.8%, 14.2% STS %, 5.0%, 9.2%, 12.8%, 14.2% 5.7%, 12.0%
6 Manufacurer Roche Diagnosics Tosoh Corporaion Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo TQ Gen. 2 hemolysae on Cobas Inegra 800 (/* ) TQ Gen. 2 whole blood on Cobas Inegra 800 (/* ) TQ Gen. 3 hemolysae on cobas c501/502 (/* ) TQ Gen. 3 whole blood on cobas c501/502 (/* ) G7 Sandard Analysis Mode (1.2 min) HLC-723G7 G7 Sandard Analysis Mode (1.2 min) HLC-723G7 G8 Sandard Analysis Mode (1.0 min) HLC-723G8 G8 Sandard Analysis Mode (1.0 min), HLC-723G8 G9, HLC-723G , , , , , K7-104W, K7-203W, 7-303W, HW-09Y K7-104W, K7-203W, 7-303W, HW-09Y E8-106W, E8-201W, 8-305W, HW-09Y E8-106W, E8-201W, 8-305W, HW-09Y B9-101W, B9-201Y, 9-301A, HW-14W , 1.667, 1.392, 0.557, 0.112, 0 g/dl ; , g/dl , , , , , 0 g/dl ; , g/dl , 0.345, 0.654, 0.901, 1.220, ; 1.437, , 0.345, 0.674, 0.935, 1.273, ; 1.437, ZS %, 10.76% JS %, 10.97% ZS %, 10.76% JS %, 10.97% ZS %, 10.76% Laboraory K K E E B 6
7 Manufacurer Tosoh Corporaion Siemens Healhcare Diagnosics Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo G9, HLC-723G9 G8 Varian Analysis Mode (1.6 min), HLC-723G8 G7 Varian Analysis Mode (2.2 min), HLC-723G7 GX HLC-723GX GX HLC-723GX G11, Sandard Analysis Mode (0.5 min), HLC-723G11 G11, Sandard Analysis Mode (0.5 min), HLC-723G11 DCA DCA Vanage B9-101W, B9-201Y, 9-301A, HW-14W F8-101W, F8-201W, F8-301W, HW-09Y M7-101Y, M7-201Y, M7-301Y, HW-09Y AX-101W, AX-201Y, AX-301Y, HW-09W AX-101W, AX-201Y, AX-301Y, HW-09W A1-101Y, A1-201Y, 1-301Y, HW-09Y A1-101Y, A1-201Y, 1-301Y, JS %, 10.97% ZS %, 10.76% ZS %, 10.76% ZS %, 10.76% JS %, 10.97% ZS %, 10.76% JS %, 10.97% B F M A A A A Laboraory HW-09Y Mindray Siemens Healhcare Diagnosics Inc. Beckman Couler, Inc. Shenzhen Genius Elecronics Co., Ld. Ion-exchange on H50/H50P Dimension Visa Flex on Visa 1500 Uni Cel DxC Syr on UniCel DxC 800 Nephelomery on Specific Proein Analyzer PA54/PA50 May , , %, 11.8% ReCCS May BA 4KD , 0.52, 0.92, 1.59, 2.28 g/dl ; 12.48, g/dl May 15 M M , 0.460, 0.869, 1.503, g/dl A1c3; g/dl 3 May
8 Manufacurer Abbo Diagnosics Nihon Kohden Corporaion Arkray, Inc. Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo (Hemolysae) on Archiec c8000 %NGSP=/ * (Whole Blood) on Archiec c8000 %NGSP=/ * (Hemolysae) on Archiec c4000 %NGSP=/ * (Whole Blood) on Archiec c4000 %NGSP=/ * Cellac Chemi on CHM-4100 (NGSP(%)=1.02* JDS(%)+0.25) ADAMS A1c HA-8160 VP mode ADAMS A1c HA-8160 TP mode ADAMS A1c HA-8160 (Ver.1) ADAMS A1c HA-8160 (Ver.4) ADAMS A1c HA-8170 ADAMS A1c HA-8180 ADAMS A1c HA-8180V Varian mode Enzymaic May UQ07, 46208UQ07, 46208UQ Enzymaic May UQ07, 46208UQ07, 46208UQ Enzymaic May UQ07, 46208UQ07, 46208UQ Enzymaic May UQ07, 46208UQ07, 46208UQ 46700UQ , ; 98, UQ , ; 98, UQ , ; 98, UQ , ; 98, May CEN %, 4.4%, 6.9%, 9.7%, 13.3% Apr , , , Apr , , , , Apr , , , Apr , , , Apr , , , Apr 15 5A1011, 4I1022, 4F1055 Apr 15 5A1011, 4I1022, 4L1401, 4F1055 Laboraory 4E74 5.4%, 10.7% 4K021Y 4E74 5.4%, 10.7% 4K001W 4E74 5.4%, 10.7% 4J004X 4E76 5.3%, 10.6% 4K031F 4E76 5.3%, 10.6% 4J081G CA84E38 5.4%, 10.7% 4J206N CA84E38 5.4%, 10.7% 4J151U 8
9 Manufacurer Arkray, Inc. Sebia Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo ADAMS A1c HA-8180V Fas mode ADAMS A1c HA-8180T ADAMS HYBRID AH ADAMS HYBRID AH ADAMS A1c HA-8181 CinQ on BioMajesy JCA-BM6010 %(NGSP)= */*10 00(IFCC)+2.15 CinQ on TBA-120FR %(NGSP)= */*10 00(IFCC)+2.15 CinQ on JCA- BM9130 %(NGSP)= */*10 00(IFCC)+2.15 CinQ on Hiachi LABOSPECT 006 %(NGSP)= */*10 00(IFCC)+2.15 Capillarys on Capillarys 2 Flex Piercing %NGSP= x [IFCC] (mmol/mol) Minicap %NGSP= x [IFCC] (mmol/mol) CAPI 3 on Capillarys 3 %NGSP= x [IFCC] (mmol/mol) Apr 15 5A1011, 4I1022, 4L1401, 4F1055 Apr 15 5A1011, 4I1022, 4L1601, 4F1055 Apr 15 5A1011, 4I1022, 4F1055 Apr 15 5A1011, 4I1022, 4F1055 Apr 15 5A1011, 4I1022, 4F1055 Enzymaic Apr 15 MFD37, MFP24 Enzymaic Apr 15 MFV07, MFQ07 Enzymaic Apr 15 MFV07, MFQ07 Enzymaic Apr 15 MFV07, MFQ07 Capillary Elecrophoresis Capillary Elecrophoresis Capillary Elecrophoresis Apr /01, 24073/01, 03073/01 Apr /01, 03043/01, 05054/01 Apr /01, 02094/80, 07104/01 Laboraory CA84E38 5.4%, 10.7% 4J151U CA84E38 5.4%, 10.7% 4J001L CA84E43 5.4%, 10.7% 4J206N CA84E43 5.4%, 10.7% 4J207N CA84E43 5.4%, 10.7%; 4J207N CAC4M15, 2.48, 7.08 (IFCC); 88.3, 94.7 CAC4M15, 2.48, 7.08 (IFCC); 88.3, 94.7 CAC4M15, 2.48, 7.08 (IFCC); 88.3, 94.7 CAC4M15, 2.48, 7.08 (IFCC); 88.3, /01, 19034/ /01, 19034/ /01, 19034/ , 83.4 mmol/mol 35.6, 83.4 mmol/mol 35.6, 83.4 mmol/mol 9
10 Manufacurer Wiener Laboraorios ROHM Co., Ld. Fujirebio Inc. Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo Turbies AA on CMD 800i X1 91.5*/ Turbies AA on CT 600i 91.5*/ Turbies AA on CM */ Turbies AA on CB 350i 91.5*/ v2 Turbies AA on CT600i 91.5*/ v2 Turbies AA on CM */ Banalys Ace on Banalys Ace NGSP = *IFCC B-analys on B- Analys S1 NGSP= * IFCC+2.15 Spochem Banalys on Spochem Banalys SI NGSP = *IFCC Rapidia Auo -L on BiOLis24i Premium Rapidia Auo -L on JCA-BM9130 AU-Synchron Reagen on AU680 Apr , 0.89, 1.56, 2.44 g/dl ; 14.8 g/dl Apr , 0.89, 1.56, 2.44 g/dl ; 14.8 g/dl Apr , 0.89, 1.56, 2.44 g/dl ; 14.8 g/dl Apr , 0.89, 1.56, 2.44 g/dl ; 14.8 g/dl Apr g/dl ; 13.0 g/dl Apr g/dl ; 13.0 g/dl Apr EV005O , 27.5, 50.9, 82.6, mmol/mol Apr EVN08O , 27.8, 52.0, 86.5, mmol/mol Apr EV004O , 27.5, 50.9, 82.6, mmol/mol Apr 15 Apr 15 Apr 15 QF40903, RF40903, SF41204 QF40903, RF40903, SF41204 F9A001, F9A001, H2A001 VF %, 4.3%, 7.0%, 9.9%, VF %, 4.3%, 7.0%, 9.9%, H1A %, 4.3%, 7.0%, 9.9%, Laboraory 10
11 Manufacurer Fujirebio Inc. Alere Technologies AS Orho Clinical Diagnosics Poine Scienific, Inc. Bio-Rad Laboraories Beckman Couler Ireland Inc. ELITech Clinical Sysems SAS Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo Rapidia Auo -L on AU680 Rapidia Auo -L on Hiachi 7170s Rapidia Auo -L on TBA-120FR Afinion / Afinion AS100 Analyzer D%A1c VITROS on VITROS 5600 D%A1c VITROS on VITROS 4600 (2- par) immunourbidi meric on AU 400 VARIANT II Varian II Turbo Ki 2.0 (screen and diagnosis) B00389 Applicaion AU400 B00389 Applicaion AU5800 (immunourbidimeric assay) on Vial Scienific Selecra ProS Boronae affiniy Apr 15 Apr 15 Apr 15 QF40903, RF40903, SF41204 QF40903, RF40903, NF41202 QF40903, RF40903, SF41204 VF %, 4.3%, 7.0%, 9.9%, VF %, 4.3%, 7.0%, 9.9%, VF %, 4.3%, 7.0%, 9.9%, Laboraory Apr ESRL #11 Apr , 0.48, 0.89, 1.47, 2.15 g/ml dha1c; , g/ml d Apr , 0.48, 0.89, 1.47, 2.15 g/ml dha1c; , Apr , AA40349, AA40350, , , , M , M R141662, R141663, R141664, R , , g/ml d 0.00%, 5.1%, 8.1%, 11.8%, 15.8% , 0.277, 0.521, 0.909, ; 8.53 T , 0.277, 0.521, 0.909, ; 8.53 R141592, R141593, R141594, R %, 10.2% NU31453B Minn 5.5%, 10.5% 31500B Minn T 5.0%, 8.0%, 11.6%, 15.5% 11
12 Manufacurer ELITech Clinical Sysems SAS Triniy Bioech Wako Pure Chemical Indusries, Ld. Sekisui Medical Co., Ld. Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo (immunourbidimeric assay) on Vial Scienific Selecra ProM G/ Boronae Affiniy on PDQ G/ Boronae Affiniy on ulra 2 G/ Boronae Affiniy on Premier 9210 Auoki on Hiachi 7170S RC20 AUTO TBA on TBA- 120FR L ype Norudia N on Hiachi LST006 L ype Norudia N on Hiachi LST008 Norudia N on Hiachi 7170S Norudia N on EV800 Boronae affiniy Boronae affiniy Boronae affiniy R141662, R141663, R141664, R , 5278, 5264, 5270 R141592, R141593, R141594, R %, 8.0%, 11.6%, 15.5% 5521, %, 11.0% PPE , , %, 11.2% PPE , 4955, 5528, 5270 AE666, AG Enzymaic 804RLL, 804RLL, 804RLL Enzymaic 803RLL, 803RLL, 803RAM Enzymaic 803RLL, 803RLL, 803RAM Enzymaic 849RJL, 850RJL, 841RJL Enzymaic 849RJL, 850RJL, 841RJL Laboraory SRL #3 SRL #3 5521, %, 11.0% SRL #3 AE , 0.94, 1.62, 2.48 g/dl ; 14.6 g/dl 5.13%, 10.83% 903RLL 3.24, ; 94.3, RAM 3.36, ; 97.2, RAM 3.36, ; 97.2, RIL 3.28, ; 92.9, RIL 3.28, ; 92.9, ReCCS 12
13 Manufacurer Sekisui Medical Co., Ld. Kyowa Medex Co., Ld.. Home Access Healh Corp Green Cross Medis Corp. Bodiech Med Inc. Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo Norudia N on TBA-120FR Norudia N on JCA-BM9130 Deerminer on DM-JACK Deerminer on JCA-BM9130 Deerminer on Hiachi 7180 Deerminer L on DM-JACK Deerminer L on JCA-BM9130 Deerminer L on Hiachi 7180 Deerminer L on TBA-120FR Red blood cellserum sripbased cassees on Beckman AU640e CERA-STAT 2000, also sold as QDx A1c Analyzer CERA-STAT 4000, also sold as Merilyzer Mericheck Analyzer ichroma Tes Enzymaic 849RJL, 850RJL, 841RJL Enzymaic 849RJL, 850RJL, 841RJL Boronae Affiniy Boronae Affiniy TaiDoc Technology Corp. Measure II on TD-4611 UMA Co., Ld Measure 364ADH, 364ADJ 387ADK, 387ADL 387ADK, 387ADL 134ADI, 134ADI 134ADI, 134ADI 134ADI, 134ADI 134ADI, 134ADI RIL 3.28, ; 92.9, RIL 3.28, ; 92.9, ADE 0.0%, 5.0%, 9.1%, 12.9%, 15.8% 505ADE 0.0%, 5.0%, 9.0%, 12.9%, 15.6% 505ADE 0.0%, 5.0%, 9.0%, 12.9%, 15.6% 308ADI 0.0%, 4.6%, 6.8%, 10.0%, 13.7% 308ADI 0.0%, 4.3%, 6.9%, 9.8%, 308ADI 0.0%, 4.3%, 6.9%, 9.8%, 308ADI 0.0%, 4.3%, 6.9%, 9.8%, Feb , A 0.019, 0.234, 0.416, 0.560, 0.977, g/dl A1c; 21.1 g/dl Feb 15 Feb 15 H04L091, H04L092, HC233AP9EW H04L091, H04L092, HC433AP9EW Jan 15 AAKYA A, A, A Jan 15 Jan ADK, 152ADK 010ADK, 152ADK Laboraory %, 5.8%, 6.5%, 8.1%, 11.2%, 15.2% 114ADK 0%, 4.3%, 8.3%, 11.5%, 15.3% 113BDK 0%, 4.6%, 7.5%, 11.9%, 15.5% Jan 15 14K %, 8.3%, 11.6%, 15.5%
14 Manufacurer Axis-Shield Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo Archiec on Archiec i Human GmbH HumaMeer A1c Boronae Fluorescence quenching Thermo Fisher Scienific Oy Bio-Rad Laboraories HumaNex A1c for Konelab, ref , hemolyzaion, 91.5*/ for Indiko, ref , hemolyzaion, 91.5*/ for Konelab, ref , On Board hemolyzaion, 91.5*/ VARIANT II Dual (A1c) VARIANT II Dual (A2/F/A1c) Jan UP %, 5.5%, 7.5%, 9.0%, 12.0%,14.5% Laboraory ESRL#12 Jan Barcode Jan F %, 11.20% Jan 15 K694, K783 K ; Jan 15 K694, K783 K ; Jan 15 K694, K783 K ; Jan , , Jan , , , , %, 10.0% XA20900 Minn 5.3%, 9.9% XA20900 Minn D-10 Dual A2/F/A1c VARIANT II TURBO VARIANT II TURBO Link VARIANT II TURBO Ki 2.0 D-10 Jan 15 Jan 15 AA40263, AA40264, AA40177 AA40261, AA40262, AA40354 Jan , , Jan , , Jan , , AA40151, AA40152 AA40284, AA , , , %, 10.2% D22250P Minn 5.7%, 10.2% A22250AJ Minn 5.2%, 10.2% S20170W Minn 5.3%, 10.2% LLV20170P Minn 5.1%, 10.2% 11840AF Minn 14
15 Manufacurer DiaSys Diagnosic Sysems GmbH Beckman Couler Ireland Inc. Bio-Rad Laboraories Bioki Lis of NGSP Cerified Mehods (Updaed 10/15, lised by dae cerified) Mehod/ Mehod Dae Reagen Calibraor Calibraor Column Insrumen Type Cerified Lo Lo Assigned Lo ne FS, No , on respons 910 ne FS, No , on Biomajesy one FS, No , 3 componen version on Hiachi 917 one FS, No , on InnovaSar OSR6192 Applicaion AU480 OSR6192 Applicaion AU640 OSR6192 Applicaion AU680 OSR6192 Applicaion AU2700 Quanex Jan , Jan , Jan , E19/ , g/dl ; 5.13, 15.2 g/dl E19/ , g/dl ; 6.30, , 19950, 19951, Jan 15 76, , 20629, 20630, g/dl 5.08%, 7.91%, 11.6%, 15.8% 5.05%, 6.60%, 10.3%, 14.2% Dec , 0.143, 0.253, 0.333, 0.586, ; T Dec , 0.143, 0.253, 0.333, 0.586, ; T Dec , 0.143, 0.253, 0.333, 0.586, ; T Dec , 0.143, 0.253, 0.333, 0.586, ; T Dec , , %, 9.25% Dec 14 B23326 B , 0.11, 0.21, 0.31, 0.55, 0.86 Laboraory D Minn 15
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