Organisation Method Certified
SD BIOSENSOR / Multicare™ System Multicare™ System 1-4-2022
SD BIOSENSOR / STANDARD™ A1cCare STANDARD™ A1cCare 1-4-2022
SD BIOSENSOR / STANDARD™ F100 STANDARD™ F100 1-4-2022
SD BIOSENSOR / STANDARD™ F200 STANDARD™ F200 1-4-2022
SD BIOSENSOR / STANDARD™ F2400 STANDARD™ F2400 1-4-2022
Shenzhen New Industries Biomedical Engineering Co., Ltd(SNIBE) Immunoassay on Biossays® 240 Plus 1-3-2022
Shenzhen New Industries Biomedical Engineering Co., Ltd(SNIBE) Immunoassay on AS-2450M 1-3-2022
Shenzhen New Industries Biomedical Engineering Co., Ltd(SNIBE) Immunoassay on Biossays® C8 1-3-2022
Shenzhen New Industries Biomedical Engineering Co., Ltd(SNIBE) Immunoassay on HITACHI LABOSPECT 008AS 1-3-2022
Suzhou Borui Sunga Medical Technology Co., Ltd. HPLC on CM-C1 Glycosylated Hemoglobin Analyzer 1-3-2022
Zybio Inc. Fluorescence Immunoassay Analyzer-Q8 Pro/Immunofluorescence 1-3-2022
A. Menarini Diagnostics S.r.l. Hb NEXT Hemoglobin Analyzer (HPLC) 1-1-2022
A. MENARINI Diagnostics S.r.l. LINX DUO Multiassay Analyzer 1-1-2022
Abbott Alinity / Hemoglobin A1c 1-1-2022
Abbott ARCHITECT c4000 / Hemoglobin A1c 1-1-2022
Abbott ARCHITECT c8000 / Hemoglobin A1c 1-1-2022
ARKRAY, Inc. ADAMS A1c AH-8290 1-1-2022
ARKRAY, Inc. CinQ HbA1c 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8160TP 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8160VP 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8161 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8170 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8180 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8180T 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8180V Fast Mode 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8180V Variant Mode 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8181 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8182 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8190V Fast Mode 1-1-2022
ARKRAY, Inc. ADAMS A1c HA-8190V Variant Mode 1-1-2022
ARKRAY, Inc. ADAMS A1c Lite HA-8380 1-1-2022
ARKRAY, Inc. ADAMS A1c Lite HA-8380V Fast Mode 1-1-2022
ARKRAY, Inc. ADAMS A1c Lite HA-8380V Variant Mode 1-1-2022
ARKRAY, Inc. The Lab 001 1-1-2022
Assel S.r.l. AS8 Hemoglobin Analyzer (HPLC) 1-1-2022
Assel S.r.l. AS9 Hemoglobin Analyzer (HPLC) 1-1-2022
Avantor Performance Materials India Limited Benesphera A10 Hemoglobin Analyzer (HPLC) 1-1-2022
Bio-rad Laboratories D10 - A1c 1-1-2022
Bio-rad Laboratories D-10 S&D 1-1-2022
Bio-rad Laboratories D-10, Dual 1-1-2022
Bio-rad Laboratories D-100 HbA1c 1-1-2022
Bio-rad Laboratories Variant II, HbA1c Dual 1-1-2022
Bio-rad Laboratories Variant II, HbA1c, NU 1-1-2022
Bio-rad Laboratories VII Turbo 2.0 - HbA1c Kit (12000447) 1-1-2022
Bio-rad Laboratories Variant II Turbo 2.0 - HbA1c 1-1-2022
Diazyme Laboratories, Inc. Diazyme Direct Enzymatic HbA1c 1-1-2022
DxGen Corp. Epithod® HbA1c Measuring System(Ep.414, Dx.HbA1c) 1-1-2022
DxGen Corp. Epithod®616 HbA1c Measuring System (Ep.616, Ep.616H) 1-1-2022
EMPECS Medical Device Co., Ltd. ASUREQUAN Analyzer 1-1-2022
Erba Lachema s.r.o ERBA Hb-Vario / Hb 820 1-1-2022
Erba Lachema s.r.o. HbA1c 2R Kit - XL-200/EM-200 1-1-2022
Erba Lachema s.r.o. HbA1c Kit - XL-1000 1-1-2022
Erba Lachema s.r.o. HbA1c Kit - XL-200/EM-200 1-1-2022
Erba Lachema s.r.o. HbA1c Kit - XL-640 1-1-2022
Erba Lachema s.r.o. HbA1c 2R Kit - XL-1000 1-1-2022
Erba Lachema s.r.o. HbA1c 2R Kit - XL-640 1-1-2022
Getein Biotech, Inc Immunofluorescence Assay/Getein1200 Immunofluorescence Quantitative Analyzer 1-1-2022
Getein Biotech, Inc Immunofluorescence Assay/Getein1600 Immunofluorescence Quantitative Analyzer 1-1-2022
Getein Biotech, Inc. Colloidal Gold/FIA8000/8600 Quantitative Immunoassay Analyzer 1-1-2022
Getein Biotech, Inc. Immunofluorescence Assay/Getein1100 Immunofluorescence Quantitative Analyzer 1-1-2022
Getein Biotech, Inc. Immunofluorescence Assay/Getein1180 Immunofluorescence Quantitative Analyzer 1-1-2022
Green Cross Medical Science Corp. GREENCARE A1c 1-1-2022
Green Cross Medical Science Corp. Hémo G Smart 1-1-2022
Green Cross Medical Science Corp. HORRON A1c 1-1-2022
Green Cross Medical Science Corp. PocketChem A1c Advanced 1-1-2022
Green Cross Medical Science Corp. QDx A1c Advance 1-1-2022
GREEN CROSS MEDIS Corp. CERA-STAT 2000 (Model: CS 2000), QDX A1c 1-1-2022
GREEN CROSS MEDIS Corp. CERA-STAT 4000(Model: CS 4000), Merilyzer MeriCheck A1c/CRP 1-1-2022
GREEN CROSS MEDIS Corp. LabonaCheck A1c (Model: MH 200), A1c Card 1-1-2022
HORIBA Medical Pointe, HbA1c Immunoturbidimetric on Mindray BA-800M 1-1-2022
Human Gesellschaft für Biochemica und Diagnostica mbH HumaNex A1c Variant/Ion-Exchange HPLC 1-1-2022
HUMAN Gesellschaft für Biochemica und Diagnostica mbH HumaStar 100/Immunoturbidimetric 1-1-2022
HUMAN Gesellschaft für Biochemica und Diagnostica mbH HumaStar 200/Immunoturbidimetric 1-1-2022
HUMAN Gesellschaft für Biochemica und Diagnostica mbH HumaStar 300SR/Immunoturbidimetric 1-1-2022
HUMAN Gesellschaft für Biochemica und Diagnostica mbH HumaStar 600/Immunoturbidimetric 1-1-2022
HUMAN Gesellschaft für Biochemica und Diagnostica mbH HumaMeter A1c/Boronate fluorescence quenching technology 1-1-2022
HUMAN Gesellschaft für Biochemica und Diagnostica mbH HumaNex A1c/HPLC 1-1-2022
IMMUNOSHOP INDIA PVT. LTD. LifeDx HBPro Hemoglobin Analyzer (HPLC) 1-1-2022
i-SENS Inc. A1Care 1-1-2022
JEOL Ltd. JCA-BM6010 1-1-2022
Jiangshan Derui Medical Science and Technology Co., LTD. T10 HbA1c Analyzer (HPLC) 1-1-2022
Labnovation Technologies,Inc. LD-500/LD-510/LD-520 Automated HbA1c Analyzer (HPLC) 1-1-2022
Labnovation Technologies,Inc. LD-560/LD-561/LD-562 Automated HbA1c Analyzer (HPLC) 1-1-2022
Labnovation Technologies,Inc. LD-600/LD-620 Automated HbA1c Analyzer (HPLC) 1-1-2022
Labnovation Technologies,Inc. LD-100/LD-120/LD-160 HbA1c Analyzer (Boronate Affinity) 1-1-2022
Maccura Biotechnology Co.,Ltd maccura G 01 1-1-2022
MDX MEDTEK DIAGNOSTICS (NETHERLANDS) B.V. HPLCline®100 1-1-2022
MED TRUST Handelsges.m.b.H. Wellion BONA HbA1c Analysis System 1-1-2022
MED TRUST Handelsges.m.b.H. Wellion CLEVER HbA1c Analysis System 1-1-2022
OSANG Healthcare Co.,Ltd Frontier and HemoCue® HbA1c 501 1-1-2022
OSANG Healthcare Co.,Ltd CLOVER A1c, CLOVER A1c Self and CHCKART 1-1-2022
OSANG Healthcare Co.,Ltd CLOVER A1c Plus 1-1-2022
Polymer Technology Systems Inc (PTS Diagnostics) A1cNow+, A1cNow SELFCHECK 1-1-2022
Polymer Technology Systems Inc (PTS Diagnostics) Tosoh G8 HbA1c 1-1-2022
Roche Diagnostics TQ HbA1c Gen. 3 (cobas c 501/502) 1-1-2022
Roche Diagnostics TQ HbA1c Gen. 3 (cobas c 503) 1-1-2022
Roche Diagnostics TQ HbA1c Gen. 3 (cobas c 513) 1-1-2022
Roche Diagnostics TQ HbA1c Gen. 3 (COBAS INTEGRA 400 plus) 1-1-2022
Roche Diagnostics International Ltd cobas HbA1c Test (cobas b 101) 1-1-2022
SEBIA CAPILLARYS HbA1c 1-1-2022
SEBIA CAPI3 HbA1c 1-1-2022
SEBIA MINICAP HbA1c 1-1-2022
Sekisui Medical Co., Ltd. Hemoglobin Analyzer RC-W (FAST mode) 1-1-2022
Sekisui Medical Co., Ltd. Hemoglobin Analyzer RC-W (VARIANT mode) 1-1-2022
Shenzhen Lifotronic Technology Co., Ltd FA-160 Lateral Flow Immunoassay Analyzer 1-1-2022
Shenzhen Lifotronic Technology Co., Ltd GH-900/GH-900Plus HbA1c Analyser 1-1-2022
Shenzhen Lifotronic Technology Co., Ltd H100/H100 Plus Hemoglobin Analyzer (HPLC) 1-1-2022
Shenzhen Lifotronic Technology Co., Ltd H6 Hemoglobin Analyzer (HPLC) 1-1-2022
Shenzhen Lifotronic Technology Co., Ltd H8 Hemoglobin Analyzer (HPLC) 1-1-2022
Shenzhen Lifotronic Technology Co., Ltd H9 Hemoglobin Analyzer(HPLC) 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS200 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS200E 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS240 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS240Pro 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS2800M 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS300 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS330E 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS360E 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS380 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS400 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS460&BS430 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS480 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS600 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS600M 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS800&BS800M 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS830 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd H50&H50P 1-1-2022
Shenzhen Mindray Bio-Medical Electronics Co.Ltd BS2000&BS2000M 1-1-2022
Siemens Healthcare Diagnostics Inc. Dimension® clinical chemistry system A1C 1-1-2022
Siemens Healthcare Diagnostics Inc. ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) 1-1-2022
Siemens Healthcare Diagnostics Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E) 1-1-2022
Siemens Healthcare Diagnostics Inc. Dimension Vista® System A1C 1-1-2022
Skyla Corporation Hsinchu Science Park Branch skyla Hi Analyzer 1-1-2022
Taidoc Technology Corporation Immunoassay on TD-4611 1-1-2022
TASCOM Co., Ltd. / R&D Center SimplexTAS™ HbA1c 1-1-2022
Thermo Fisher Scientific Oy Indiko™ / 981947, 981948 HbA1c 1-1-2022
Thermo Fisher Scientific Oy Konelab™ / 981947, 981948 HbA1c 1-1-2022
Tosoh Corporation HLC-723G11 1-1-2022
Tosoh Corporation HLC-723G8 1-1-2022
Tosoh Corporation HLC-723GX 1-1-2022
Trinity Biotech Premier Hb9210™ 1-1-2022
Trivitron Healthcare (P). Ltd. Nano H110 Hemoglobin Analyzer (HPLC) 1-1-2022
Trivitron Healthcare (P). Ltd. Nano H5 HbA1c Analyser 1-1-2022
Werfen ILab Aries/HbA1c (Manual pretreatment) 1-1-2022
Werfen ILab Taurus/HbA1c (Manual pretreatment) 1-1-2022
Wuxi Biohermes Bio&Medical Technology Co., Ltd A1C EZ 2.0 Glycohemoglobin Analysis System 1-1-2022
Wuxi Biohermes Bio&Medical Technology Co., Ltd A1cChek Express Glycohemoglobin Analysis System 1-1-2022
Wuxi Biohermes Bio&Medical Technology Co., Ltd A1cChek Pro Glycohemoglobin Analysis System 1-1-2022
Wuxi Biohermes Bio&Medical Technology Co., Ltd BH60 Automatic Glycohemoglobin Analysis System 1-1-2022
Wuxi Biohermes Bio&Medical Technology Co., Ltd GluCoA1c Blood Glucose and Glycohemoglobin Analysis System 1-1-2022
Wuxi Biohermes Bio&Medical Technology Co., Ltd HC-880 Automatic Glycohemoglobin Analysis System 1-1-2022
ZOVEC HEALTHCARE PVT. LTD. Z-Hb Confirm Automated Hemoglobin Analyzer (HPLC) 1-1-2022
HORIBA, Ltd. Banalyst HbA1c/Yumizen M100 Banalyst 1-10-2021
Changsha Sinocare Inc. A1CNow Self Check 1-8-2021
Changsha Sinocare Inc. A1CNow+ 1-8-2021
Changsha Sinocare Inc. iCARE-2000 1-8-2021
Changsha Sinocare Inc. iCARE-2100 1-8-2021
Changsha Sinocare Inc. PCH-100 1-8-2021
Changsha Sinocare Inc. PCH-50 1-8-2021
Goldsite Diagnostics Inc. Aristo 1-8-2021
Goldsite Diagnostics Inc. Astep 1-8-2021
Goldsite Diagnostics Inc. Astep PLUS 1-8-2021
Goldsite Diagnostics Inc. GPP-100 1-8-2021
Goldsite Diagnostics Inc. GSH-60 1-8-2021
Goldsite Diagnostics Inc. Omlipo 1-8-2021
Hunan Yonghe-Sun Biotechnology Co.,Ltd YH-30 Glycohemoglobin Analyzer (HPLC) 1-8-2021
Suzhou Sepax Technologies, Inc GlyHb-100 Automatic HbA1c Analyzer 1-8-2021
蓝怡(湖南)医疗器械有限公司 AH600, Standard Analysis Mode (1 min) 1-8-2021
Shanghai Medconn Biotechnology Co.,Ltd. AU5800 (Latex agglutination) 1-7-2021
Shanghai Medconn Medical Technology Co.,Ltd. MQ-2000PT 1-7-2021
Shanghai Medconn Medical Technology Co.,Ltd. MQ-6000 1-7-2021
Shanghai Medconn Medical Technology Co.,Ltd. MQ-8000 1-7-2021
Shanghai Medconn Medical Technology Co.,Ltd. MQ-8000PT 1-7-2021
WELLS BIO, INC. careSURE™ Analyzer 100 1-7-2021
Abbott Diagnostics Technologies AS AFINION™ 2/ AFINION™ HbA1c 1-6-2021
Abbott Diagnostics Technologies AS AFINION™ 2/ AFINION™ HbA1c Dx 1-6-2021
Abbott Diagnostics Technologies AS Alere Afinion™ AS100 Analyzer/ AFINION™ HbA1c Dx 1-6-2021
Abbott Diagnostics Technologies AS NycoCard™ READER II/ NycoCard™ HbA1c 1-6-2021
Abbott Diagnostics Technologies AS Alere Afinion™ AS100 Analyzer/ AFINION™ HbA1c 1-6-2021
Aidian Oy QuikRead go HbA1c 1-6-2021
biosurfit, S.A. spinit® HbA1c test 1-6-2021
DiaSys Diagnostic Systems GmbH HbA1c net FS, BioMajesty®JCA-BM6010/C 1-6-2021
DiaSys Diagnostic Systems GmbH HbA1c net FS, Sysmex BX-3010 1-6-2021
DiaSys Diagnostic Systems GmbH HbA1c net FS, respons®910 1-6-2021
DiaSys Diagnostic Systems GmbH oneHbA1c IS, InnovaStar® 1-6-2021
DiaSys Diagnostic Systems GmbH oneHbA1c FS, 2 components, respons®910 1-6-2021
DiaSys Diagnostic Systems GmbH oneHbA1c FS, 2 components, respons®920 1-6-2021
Dr. Müller Gerätebau GmbH HbA1c ID, SUPER ID clinchem 1-6-2021
EKF Diagnostic GmbH Quo-Lab HbA1c 1-6-2021
EKF Diagnostic GmbH Quo-Test HbA1c 1-6-2021
LINEAR CHEMICALS S.L.U. HbA1c TURBIDIMETRIC 1-6-2021
Nova Biomedical Allegro HbA1c 1-6-2021
Siemens Healthcare Diagnostics Atellica DCA 1-6-2021
Siemens Healthcare Diagnostics Vantage DCA 1-6-2021
Trinity Biotech Tri-stat 1 1-6-2021
Trinity Biotech Tri-stat 2 1-6-2021