Organisation Method Certified
ACON Laboratories,Inc. and Acon Biotech(Hangzhou)Co.,Ltd. FIAflex Fluorescent Immunoassay Analyzer, FIAflex HbA1c FIA Test 1-8-2023
ACON Laboratories,Inc.and Acon Biotech(Hangzhou)Co.,Ltd. On Call MultiPro Analyzer, On Call MultiPro HbA1c test kit 1-8-2023
ACON Laboratories,Inc.and Acon Biotech(Hangzhou)Co.,Ltd. On Call A1c HbA1c Analyzer, On Call A1c HbA1c test kit 1-8-2023
Changsha Sinocare Inc. A1CNow + 1-8-2023
Changsha Sinocare Inc. A1CNow Self Check 1-8-2023
Changsha Sinocare Inc. iCARE-1000 1-8-2023
Changsha Sinocare Inc. iCARE-2000 1-8-2023
Changsha Sinocare Inc. iCARE-2100 1-8-2023
Changsha Sinocare Inc. PCH-100 1-8-2023
Changsha Sinocare Inc. PCH-50 1-8-2023
Changsha Sinocare Inc. iCARE-2200 1-8-2023
Goldsite Diagnostics Inc. A1c Go/Affinity chromatography 1-8-2023
Goldsite Diagnostics Inc. Aristo/Immuno Assay 1-8-2023
Goldsite Diagnostics Inc. Aristo Ur/Immuno Assay 1-8-2023
Goldsite Diagnostics Inc. Astep/Immuno Assay 1-8-2023
Goldsite Diagnostics Inc. Astep PLUS/Immuno Assay 1-8-2023
Goldsite Diagnostics Inc. GPP-100/Immuno Assay 1-8-2023
Goldsite Diagnostics Inc. GSH-60/Ion-Exchange chromatography 1-8-2023
Goldsite Diagnostics Inc. Nephstar/Immuno Assay 1-8-2023
Goldsite Diagnostics Inc. Omlipo/Immuno Assay 1-8-2023
Shenzhen Poweray Biotechnology CO., LTD Boronate affinity chromatography /HbA1c analysis PR603/PR606/PR303 1-8-2023
Xiamen Biotime Biotechnology Co., Ltd. BIOT-YG-I FIA Analyzer 1-8-2023
Xiamen Biotime Biotechnology Co., Ltd. HLC-100 Fully Automated HbA1c Analyzer (HPLC) 1-8-2023
蓝怡科技集团股份有限公司 AH600, Standard Analysis Mode (1 min) 1-8-2023
Abbott Diagnostics Technologies AS AFINION™ 2/ AFINION™ HbA1c Dx 1-6-2023
Abbott Diagnostics Technologies AS Alere Afinion™ AS100 / AFINION™ HbA1c Dx 1-6-2023
Abbott Diagnostics Technologies AS NycoCard™ READER II / NycoCard™ HbA1c 1-6-2023
Abbott Diagnostics Technologies AS AFINION™ 2/ AFINION™ HbA1c 1-6-2023
Abbott Diagnostics Technologies AS Alere Afinion™ AS100 / AFINION™ HbA1c 1-6-2023
Aidian Oy QuikRead go HbA1c 1-6-2023
biosurfit, S.A. spinit® HbA1c test 1-6-2023
DiaSys Diagnostic Systems GmbH HbA1c net FS, manual hemolysis, BioMajesty®JCA-BM6010/C 1-6-2023
DiaSys Diagnostic Systems GmbH HbA1c net FS, onboard hemolysis, BioMajesty®JCA-BM6010/C 1-6-2023
DiaSys Diagnostic Systems GmbH HbA1c net FS, onboard hemolysis, Sysmex BX-3010 1-6-2023
DiaSys Diagnostic Systems GmbH HbA1c net FS, onboard hemolysis, respons®910 1-6-2023
DiaSys Diagnostic Systems GmbH oneHbA1c FS, BioMajesty®JCA-BM6010/C 1-6-2023
DiaSys Diagnostic Systems GmbH oneHbA1c IS, InnovaStar® 1-6-2023
DiaSys Diagnostic Systems GmbH oneHbA1c FS, respons®910 1-6-2023
DiaSys Diagnostic Systems GmbH oneHbA1c FS, respons®920 1-6-2023
Dr. Müller Gerätebau GmbH HbA1c ID, SUPER ID clinchem 1-6-2023
EKF Diagnostic GmbH Quo-Lab HbA1c 1-6-2023
EKF Diagnostic GmbH Quo-Test HbA1c 1-6-2023
HUMAN Gesellschaft für Biochemica und Diagnostica mbH HumaMeter A1c/Boronate fluorescence quenching technology 1-6-2023
LumiraDx LumiraDx HbA1c 1-6-2023
Nova Biomedical Allegro HbA1c 1-6-2023
Siemens Healthcare Diagnostics Atellica DCA 1-6-2023
Siemens Healthcare Diagnostics Vantage DCA 1-6-2023
Ensayos y Tamizajes de México, S.A. de C.V. Finecare FIA Meter(Fluorescence Immunoassay) 1-4-2023
Ensayos y Tamizajes de México, S.A. de C.V. Finecare FIA Meter Plus(Fluorescence Immunoassay) 1-4-2023
Guangzhou Wondfo Biotech Co., Ltd. Finecare FIA Meter(Fluorescence Immunoassay) 1-4-2023
Guangzhou Wondfo Biotech Co., Ltd. Finecare FIA Meter Plus(Fluorescence Immunoassay) 1-4-2023
Guangzhou Wondfo Biotech Co., Ltd. Finecare FIA Meter II Plus SE(Fluorescence Immunoassay) 1-4-2023
Guangzhou Wondfo Biotech Co., Ltd. Finecare FIA Meter III Plus(Fluorescence Immunoassay) 1-4-2023
SD Biosensor STANDARD™ F200 1-4-2023
SD Biosensor STANDARD™ F2400 1-4-2023
SD Biosensor, Inc STANDARD™ A1cCare 1-4-2023
SD Biosensor, Inc MultiCare™ System 1-4-2023
Shenzhen Ultra-Diagnostics Biotec. Co., Ltd. Glycohemoglobin (HbA1c) Rapid Assay Kit (Boronate Affinity Chromatography) 1-4-2023
Zybio Inc. Fluorescence Immunoassay Analyzer-Q8 Pro/Immunofluorescence 1-4-2023
Guangzhou Decheng Biotechnology Co., Ltd. Immunofluorescence Analyzer (Model No.: CHF200) 1-3-2023
Guangzhou Decheng Biotechnology Co., Ltd. Immunofluorescence Analyzer (Model No.: CHF600) 1-3-2023
Hunan Yonghe-Sun Biotechnology Co.,Ltd YH-30 Glycohemoglobin Analyzer (HPLC) 1-3-2023
Shenzhen New Industries Biomedical Engineering Co.,Ltd(SNIBE) Immunoassay on Biossays® 240 Plus 1-3-2023
Shenzhen New Industries Biomedical Engineering Co.,Ltd(SNIBE) Immunoassay on Biossays® C8 1-3-2023
Shenzhen New Industries Biomedical Engineering Co.,Ltd(SNIBE) Immunoassay on Biossays® CX8 1-3-2023
Shenzhen New Industries Biomedical Engineering Co.,Ltd(SNIBE) Immunoassay on HITACHI LABOSPECT 008AS 1-3-2023
1SENS Dx Inc. RapidFor™- FIAPresto™ Immunofluorescence Analyzer 1-1-2023
Bifour Biotech Inc. RapidFor™- FIAPresto™ Immunofluorescence Analyzer 1-1-2023
A. Menarini Diagnostics S.r.l. Hb NEXT Hemoglobin Analyzer 1-1-2023
A. MENARINI Diagnostics S.r.l. LINX DUO Multiassay Analyzer 1-1-2023
Abbott Alinity / Hemoglobin A1c 1-1-2023
Abbott ARCHITECT c4000 / Hemoglobin A1c 1-1-2023
Abbott ARCHITECT c8000 / Hemoglobin A1c 1-1-2023
ARKRAY, Inc ADAMS A1c HA-8180T 1-1-2023
ARKRAY, Inc ADAMS A1c HA-8180V Fast Mode 1-1-2023
ARKRAY, Inc ADAMS HA-8180V Variant Mode 1-1-2023
ARKRAY, Inc ADAMS A1c HA-8181 1-1-2023
ARKRAY, Inc ADAMS A1c HA-8182 1-1-2023
ARKRAY, Inc. ADAMS A1c AH-8290 1-1-2023
ARKRAY, Inc. CinQ HbA1c 1-1-2023
ARKRAY, Inc. ADAMS A1c HA-8180 1-1-2023
ARKRAY, Inc. ADAMS A1c HA-8190V Fast Mode 1-1-2023
ARKRAY, Inc. ADAMS A1c HA-8190V Variant Mode 1-1-2023
ARKRAY, Inc. ADAMS A1c Lite HA-8380 1-1-2023
ARKRAY, Inc. ADAMS A1c Lite HA-8380V Fast Mode 1-1-2023
ARKRAY, Inc. ADAMS A1c Lite HA-8380V Variant Mode 1-1-2023
ARKRAY, Inc. The Lab 001 1-1-2023
Assel S.r.l. AS8 Hemoglobin Analyzer 1-1-2023
Assel S.r.l. AS9 Hemoglobin Analyzer 1-1-2023
Bio-rad Laboratories Variant II, HbA1c Dual 1-1-2023
Bio-Rad Laboratories D-10 HbA1c Monitoring 1-1-2023
Bio-Rad Laboratories D-10 HbA1c S&D 1-1-2023
Bio-Rad Laboratories D-10, Dual 1-1-2023
Bio-Rad Laboratories D-100 HbA1c 1-1-2023
Bio-Rad Laboratories Variant II, HbA1c, NU 1-1-2023
Bio-Rad Laboratories VII Turbo 2.0 - HbA1c Kit (12000447) 1-1-2023
Bio-Rad Laboratories Variant II Turbo 2.0 - HbA1c 1-1-2023
Boditech Med Inc. HbA1c on AFIAS-1 1-1-2023
Boditech Med Inc. HbA1c on AFIAS-10 1-1-2023
Boditech Med Inc. HbA1c on AFIAS-3 1-1-2023
Boditech Med Inc. HbA1c on AFIAS-6 1-1-2023
Boditech Med Inc. HbA1c on EZ POC 1-1-2023
Boditech Med Inc. HbA1c on ichroma™ II 1-1-2023
Boditech Med Inc. HbA1c on ichroma™ III 1-1-2023
Boditech Med Inc. HbA1c on ichroma™ M3 1-1-2023
Boditech Med Inc. HbA1c on ichroma™ Reader 1-1-2023
Boditech Med Inc. HbA1c on ichroma™-50 PLUS 1-1-2023
Boditech Med Inc. HbA1c Neo on AFIAS-1 1-1-2023
Boditech Med Inc. HbA1c Neo on AFIAS-10 1-1-2023
Boditech Med Inc. HbA1c Neo on AFIAS-3 1-1-2023
Boditech Med Inc. HbA1c Neo on AFIAS-6 1-1-2023
Boditech Med Inc. HbA1c Neo on EZ POC 1-1-2023
Boditech Med Inc. HbA1c Neo on ichroma™ Reader 1-1-2023
Boditech Med Inc. HbA1c Neo on ichroma™ II 1-1-2023
Boditech Med Inc. HbA1c Neo on ichroma™ M3 1-1-2023
Boditech Med Inc. HbA1c Neo on ichroma™-50 PLUS 1-1-2023
Boditech Med Inc. HbA1c Neo on ichroma™ III 1-1-2023
Boditech Med Inc. HbA1c Neo on QDx Instacheck™ 1-1-2023
Boditech Med Inc. HbA1c on QDx Instacheck™ 1-1-2023
CareforU. Co. Ltd CareBuddy Multi/ CareBuddy HbA1c, HUBI DIA/ HUBI A1c [Model name: CFU-D1/CFU-DC1] 1-1-2023
Diazyme Laboratories, Inc. Diazyme Direct Enzymatic HbA1c 1-1-2023
DxGen Corp. Epithod® HbA1c Measuring System(Ep.414, Dx.HbA1c) 1-1-2023
DxGen Corp. Epithod®616 HbA1c Measuring System (Ep.616, Ep.616H, Ep.616HA) 1-1-2023
EMPECS Medical Device Co., Ltd. ASUREQUAN Analyzer 1-1-2023
Erba Lachema s.r.o ERBA Hb-Vario / Hb-820 1-1-2023
Erba Lachema s.r.o. HbA1c 2R Kit - XL-200 1-1-2023
Erba Lachema s.r.o. HbA1c 2R Kit - XL-640 1-1-2023
Erba Lachema s.r.o. HbA1c Kit - XL-1000 1-1-2023
Erba Lachema s.r.o. HbA1c Kit - XL-200 1-1-2023
Erba Lachema s.r.o. HbA1c Kit - XL-640 1-1-2023
Erba Lachema s.r.o. HbA1c 2R Kit - XL-1000 1-1-2023
GC MEDIS Corp. CERA-STAT 4000(Model: CS 4000), Merilyzer MeriCheck A1c/CRP 1-1-2023
GC MEDIS Corp. LabonaCheck A1c (Model: MH 200), A1c Card 1-1-2023
GC MEDIS Corp. CERA-STAT 2000 (Model: CS 2000), QDX A1c 1-1-2023
Getein Biotech, Inc Immunofluorescence Assay/Getein1180 Immunofluorescence Quantitative Analyzer 1-1-2023
Getein Biotech, Inc chemiluminescent immunoassay/MAGICL 6000 Chemiluminescence Immunoassay Analyzer 1-1-2023
Getein Biotech, Inc. Colloidal Gold/FIA8000/8600 Quantitative Immunoassay Analyzer 1-1-2023
Getein Biotech, Inc. Immunofluorescence Assay/Getein1100 Immunofluorescence Quantitative Analyzer 1-1-2023
Getein Biotech, Inc. Immunofluorescence Assay/Getein1160 Immunofluorescence Quantitative Analyzer 1-1-2023
Getein Biotech, Inc. Immunofluorescence Assay/Getein1200 Immunofluorescence Quantitative Analyzer 1-1-2023
Getein Biotech, Inc. Immunofluorescence Assay/Getein1600 Immunofluorescence Quantitative Analyzer 1-1-2023
Getein Biotech, Inc. Immunofluorescence Assay/ Getein 208 Hand-held Integrated System 1-1-2023
Green Cross Medical Science Corp. GREENCARE A1c 1-1-2023
Green Cross Medical Science Corp. Hémo G Smart 1-1-2023
Green Cross Medical Science Corp. HORRON A1c 1-1-2023
Green Cross Medical Science Corp. PocketChem A1c Advanced 1-1-2023
Green Cross Medical Science Corp. QDx A1c Advance 1-1-2023
Human Gesellschaft für Biochemica und Diagnostica mbH HumaNex A1c Variant Analyzer 1-1-2023
Human Gesellschaft fur Biochemica und Diagnostica mbH HumanNex A1c 1-1-2023
Human Gesellschaft für Biochemica und Diagnostica mbH HumaStar 100 / Immunoturbidimetric 1-1-2023
Human Gesellschaft für Biochemica und Diagnostica mbH HumaStar 600 / Immunoturbidimetric 1-1-2023
Human Gesellschaft für Biochemica und Diagnostica mbH HumaMeter A1c/ Boronate fluorescence quenching technology 1-1-2023
Human Gesellschaft für Biochemica und Diagnostica mbH HumaNex A1c Variant / HPLC 1-1-2023
Hunan Mindray Medical Technology Co., Ltd. Hitachi LABOSPECT 008AS 1-1-2023
Hunan Mindray Medical Technology Co., Ltd. Beckman Coulter AU5800 1-1-2023
Hunan Mindray Medical Technology Co., Ltd. Roche Cobas 8000 c701 1-1-2023
i-SENS Inc. A1Care 1-1-2023
JEOL Ltd. JCA-BM6010 1-1-2023
Labnovation Technologies, Inc. LD-100/LD-120/LD-160 HbA1c Analyzer (Boronate Affinity) 1-1-2023
Labnovation Technologies, Inc. LD-500/LD-510/LD-520 Automated HbA1c Analyzer (HPLC) 1-1-2023
Labnovation Technologies, Inc. LD-560/LD-561/LD-562 Automated HbA1c Analyzer (HPLC) 1-1-2023
Labnovation Technologies, Inc. LD-600/LD-620 Automated HbA1c Analyzer (HPLC) 1-1-2023
Maccura Biotechnology Co.,Ltd maccura G 01 1-1-2023
MDX Medtek Diagnostics (Netherlands) B.V. HPLCline® 100 Hemoglobin Analyzer 1-1-2023
MED TRUST Handelsges.m.b.H. Wellion BONA HbA1c Analysis System 1-1-2023
MED TRUST Handelsges.m.b.H. Wellion CLEVER HbA1c Analysis System 1-1-2023
OSANG Healthcare Frontier and HemoCue HbA1c 501 1-1-2023
OSANG Healthcare Clover A1c Expert 1-1-2023
OSANG Healthcare Clover A1c Plus 1-1-2023
OSANG Healthcare Clover A1c, Clover A1c self and CHECKART 1-1-2023
Polymer Technology Systems Inc (PTS Diagnostics) A1CNow+, A1CNow SELFCHECK 1-1-2023
Polymer Technology Systems Inc (PTS Diagnostics) Tosoh G8 HbA1c 1-1-2023
PZ Cormay S.A. DIACARE 10 Hemoglobin HPLC System 1-1-2023
PZ Cormay S.A. DIACARE 110 STAT Hemoglobin HPLC System 1-1-2023
Roche Diagnostics TQ HbA1c Gen. 3 (cobas c 501/502) 1-1-2023
Roche Diagnostics TQ HbA1c Gen. 3 (cobas c 503) 1-1-2023
Roche Diagnostics TQ HbA1c Gen. 3 (cobas c 513) 1-1-2023
Roche Diagnostics TQ HbA1c Gen. 3 (COBAS INTEGRA 400 plus) 1-1-2023
Roche Diagnostics International Ltd cobas HbA1c Test (cobas b 101) 1-1-2023
SEBIA CAPILLARYS HbA1c 1-1-2023
SEBIA CAPI3 HbA1c 1-1-2023
SEBIA MINICAP HbA1c 1-1-2023
Sekisui Medical Co., Ltd. Hemoglobin Analyzer RC-W (FAST mode) 1-1-2023
Sekisui Medical Co., Ltd. Hemoglobin Analyzer RC-W (VARIANT mode) 1-1-2023
Shanghai Medconn Biotechnology Co.,Ltd. AU5800 (Latex agglutination) 1-1-2023
Shanghai Medconn Medical Technology Co.,Ltd. MQ-2000PT 1-1-2023
Shanghai Medconn Medical Technology Co.,Ltd. MQ-3000 1-1-2023
Shanghai Medconn Medical Technology Co.,Ltd. MQ-3000PT 1-1-2023
Shanghai Medconn Medical Technology Co.,Ltd. MQ-6000 1-1-2023
Shanghai Medconn Medical Technology Co.,Ltd. MQ-8000 1-1-2023
Shanghai Medconn Medical Technology Co.,Ltd. MQ-8000PT 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd FA-100 Lateral Flow Immunoassay Analyzer 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd FA-160 Lateral Flow Immunoassay Analyzer 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd GH-900 HbA1c Analyser 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd GH-900Plus HbA1c Analyser 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd H100 Hemoglobin Analyzer 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd H100Plus Hemoglobin Analyzer 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd H6 Hemoglobin Analyzer 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd H8 Hemoglobin Analyzer 1-1-2023
Shenzhen Lifotronic Technology Co., Ltd H9 Hemoglobin Analyzer 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS200 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS2000&2000M 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS200E 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS240 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS240Pro 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS2800M 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS300 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS330E 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS360E 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS380 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS400 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS460&430 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS480 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS600 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS600M 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS800&800M 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BS830 1-1-2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. H50&H50P 1-1-2023
Siemens Healthcare Diagnostics Inc. Dimension® clinical chemistry system A1C 1-1-2023
Siemens Healthcare Diagnostics Inc. ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) 1-1-2023
Siemens Healthcare Diagnostics Inc. Atellica® CH Enzymatic Hemoglobin A1c (A1c_E) 1-1-2023
Skyla Corporation Hsinchu Science Park Branch skyla Hi Analyzer 1-1-2023
TaiDoc Technology Corporation Immunoassay on TD-4611 1-1-2023
TASCOM Co., Ltd. SimplexTAS™ HbA1c 1-1-2023
Thermo Fisher Scientific Oy Indiko™ / 981947, 981948 HbA1c 1-1-2023
Thermo Fisher Scientific Oy Konelab™ Prime 30 / 981947, 981948 HbA1c 1-1-2023
Tosoh Corporation HLC-723G11 1-1-2023
Tosoh Corporation HLC-723G8 1-1-2023
Tosoh Corporation HLC-723GX 1-1-2023
Trinity Biotech Premier Hb9210™ 1-1-2023
Vitrosens Biyoteknoloji Ltd. Şti. RapidFor™- FIAPresto™ Immunofluorescence Analyzer 1-1-2023
Werfen ILab Aries/HbA1c (Manual pretreatment) 1-1-2023
Wuxi Biohermes Bio&Medical Technology Co., Ltd A1C EZ 2.0 Glycohemoglobin Analysis System 1-1-2023
Wuxi Biohermes Bio&Medical Technology Co., Ltd A1cChek Express Glycohemoglobin Analysis System 1-1-2023
Wuxi Biohermes Bio&Medical Technology Co., Ltd A1cChek Pro Glycohemoglobin Analysis System 1-1-2023
Wuxi Biohermes Bio&Medical Technology Co., Ltd BH60 Automatic Glycohemoglobin Analysis System 1-1-2023
Wuxi Biohermes Bio&Medical Technology Co., Ltd GluCoA1c Blood Glucose and Glycohemoglobin Analysis System 1-1-2023
WELLS BIO, INC. careSURE™ Analyzer 100 1-11-2022
HORIBA, Ltd. Banalyst HbA1c/Yumizen M100 Banalyst 1-10-2022