|
Organisation
|
Method
|
Certified
|
|
HORIBA, Ltd.
|
B-analyst HbA1c/B-analyst S1
|
1-10-2020
|
|
Changsha Sinocare Inc.
|
iCARE-2000
|
1-7-2020
|
|
Changsha Sinocare Inc.
|
iCARE-2100
|
1-7-2020
|
|
Changsha Sinocare Inc.
|
PCH-100
|
1-7-2020
|
|
Abbott Diagnostics Technologies AS
|
AFINION™ 2 / AFINION™ HbA1c
|
1-6-2020
|
|
Abbott Diagnostics Technologies AS
|
AFINION™ 2 / AFINION™ HbA1c Dx
|
1-6-2020
|
|
Abbott Diagnostics Technologies AS
|
Alere Afinion™ AS100 Analyzer / AFINION™ HbA1c Dx
|
1-6-2020
|
|
Abbott Diagnostics Technologies AS
|
NycoCard™ READER II / NycoCard™ HbA1c
|
1-6-2020
|
|
Abbott Diagnostics Technologies AS
|
Alere Afinion™ AS100 Analyzer / AFINION™ HbA1c
|
1-6-2020
|
|
Aidian Oy
|
QuikRead go HbA1c
|
1-6-2020
|
|
biosurfit SA
|
spinit® HbA1c test
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, BioMajesty®JCA-BM6010/C
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, Sysmex BX-3010
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, Hitachi 917
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, respons®910
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 2 components, Hitachi 917
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 2 components, respons®910
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 2 components, respons®920
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 3 components, Hitachi 917
|
1-6-2020
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c IS, InnovaStar®
|
1-6-2020
|
|
Dr. Müller Gerätebau GmbH
|
HbA1c ID, SUPER ID chlinchem
|
1-6-2020
|
|
EKF Diagnostic GmbH
|
Quo-Lab HbA1c
|
1-6-2020
|
|
EKF Diagnostic GmbH
|
Quo-Test HbA1c
|
1-6-2020
|
|
Linear Chemicals S.L.U.
|
HbA1c Turbidimetric
|
1-6-2020
|
|
Nova Biomedical
|
Allegro HbA1c
|
1-6-2020
|
|
Siemens Healthcare Diagnostics
|
Vantage DCA
|
1-6-2020
|
|
Trinity Biotech
|
Tri-stat Analyzer
|
1-6-2020
|
|
Trinity Biotech
|
Tri-stat 2 Analyzer
|
1-6-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - CinQ HbA1c
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8160TP
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8160VP
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8161
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8170
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8180
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8180T
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8180V Fast Mode
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8180V Variant Mode
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8181
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8190V Fast Mode
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8190V Variant Mode
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c Lite HA-8380
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c Lite HA-8380V Fast Mode
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c Lite HA-8380V Variant Mode
|
1-1-2020
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - The Lab 001
|
1-1-2020
|
|
ASSEL srl
|
AS8 Hemoglobin Analyzer(HPLC)/Ion-exchange HPLC
|
1-1-2020
|
|
ASSEL srl
|
AS9 Hemoglobin Analyzer(HPLC) /Ion-exchange HPLC
|
1-1-2020
|
|
Bio-Rad Laboratories
|
D-10 HbA1c
|
1-1-2020
|
|
Bio-Rad Laboratories
|
D-10, Dual
|
1-1-2020
|
|
Bio-Rad Laboratories
|
D-10 Screening and Diagnosis Kit
|
1-1-2020
|
|
Bio-Rad Laboratories
|
D-100, HbA1c
|
1-1-2020
|
|
Bio-Rad Laboratories
|
Variant II Turbo HbA1c Kit- 2.0 (12000447)
|
1-1-2020
|
|
Bio-Rad Laboratories
|
Variant II, HbA1c Dual
|
1-1-2020
|
|
Bio-Rad Laboratories
|
Variant II, HbA1c Nu
|
1-1-2020
|
|
Bio-Rad Laboratories
|
Variant II Turbo, HbA1c/2.0
|
1-1-2020
|
|
Diazyme Laboratories, Inc.
|
Diazyme Direct Enzymatic HbA1c Assay
|
1-1-2020
|
|
DxGen Corp.
|
Epithod®414 HbA1c Measuring System
|
1-1-2020
|
|
DxGen Corp.
|
Epithod®616 HbA1c Measuring System
|
1-1-2020
|
|
Erba Lachema s.r.o.
|
ERBA Hb-Vario
|
1-1-2020
|
|
Erba Lachema s.r.o.
|
HbA1c Kit – XL-1000
|
1-1-2020
|
|
Erba Lachema s.r.o.
|
HbA1c Kit – XL-200/EM-200
|
1-1-2020
|
|
Erba Lachema s.r.o.
|
HbA1c Kit – XL 640
|
1-1-2020
|
|
Getein Biotech, Inc.
|
Colloidal Gold/FIA8000/8600
Quantitative Immunoassay Analyzer
|
1-1-2020
|
|
Getein Biotech, Inc.
|
Immunofluorescence Assay/Getein1100 Immunofluorescence Quantitative Analyzer
|
1-1-2020
|
|
Getein Biotech, Inc.
|
Immunofluorescence Assay/Getein1600 Immunofluorescence Quantitative Analyzer
|
1-1-2020
|
|
Getein Biotech, Inc.
|
Immunofluorescence Assay/Getein3200
Integrated System
|
1-1-2020
|
|
Green Cross Medical Science Corp.
|
GREENCARE A1c
|
1-1-2020
|
|
Green Cross Medical Science Corp.
|
QDx A1c Advance
|
1-1-2020
|
|
Green Cross Medical Science Corp.
|
Hémo G Smart
|
1-1-2020
|
|
Green Cross Medical Science Corp.
|
PocketChem A1c Advanced
|
1-1-2020
|
|
Green Cross Medical Science Corp.
|
HORRON A1c
|
1-1-2020
|
|
GREEN CROSS MEDIS Corp.
|
CERA-STAT 2000(Model: CS 2000), QDX A1c
|
1-1-2020
|
|
GREEN CROSS MEDIS Corp.
|
CERA-STAT 4000(Model: CS 4000),
Merilyzer MeriCheck A1c/CRP
|
1-1-2020
|
|
GREEN CROSS MEDIS Corp.
|
LabonaCheck A1c (Model: MH 200), A1c Card
|
1-1-2020
|
|
Guangzhou Wondfo Biotech Co., Ltd.
|
Finecare FIA Meter (Fluorescence Immunoassay)
|
1-1-2020
|
|
Guangzhou Wondfo Biotech Co., Ltd.
|
Finecare FIA Meter Plus (Fluorescence Immunoassay)
|
1-1-2020
|
|
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 600/Immunoturbidimetric
|
1-1-2020
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 100/Immunoturbidimetric
|
1-1-2020
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 300SR/Immunoturbidimetric
|
1-1-2020
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaMeter A1c/Boronate flourescence quenching technology
|
1-1-2020
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 200/Immunoturbidimetric
|
1-1-2020
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaNex A1c/HPLC
|
1-1-2020
|
|
i-SENS Inc.
|
A1Care
|
1-1-2020
|
|
JEOL.Ltd
|
JCA-BM 6010/C
|
1-1-2020
|
|
JEOL.Ltd
|
JCA-ZS050
|
1-1-2020
|
|
Jiangshan Derui Medical Science and Technology
Co., Ltd.
|
T10 HbA1c Analyzer
|
1-1-2020
|
|
Labnovation Technologies, Inc.
|
LD-100/LD-120/LD-160 HbA1c Analyzer (Boronate Affinity)
|
1-1-2020
|
|
Labnovation Technologies, Inc.
|
LD-500/LD-510/LD-520 Automated HbA1c Analyzer (HPLC)
|
1-1-2020
|
|
Labnovation Technologies, Inc.
|
LD-560/LD-561/LD-562 Automated HbA1c Analyzer (HPLC)
|
1-1-2020
|
|
Labnovation Technologies, Inc.
|
LD-600/LD-620 Automated HbA1c Analyzer (HPLC)
|
1-1-2020
|
|
MedTest Dx
|
Pointe Scientific, HbA1c Immunoturbidimetric on AU400
|
1-1-2020
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8160TP
|
1-1-2020
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8160VP
|
1-1-2020
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8180T
|
1-1-2020
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8180V FastMode
|
1-1-2020
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8180V VariantMode
|
1-1-2020
|
|
OSANG Healthcare Co.,Ltd
|
Frontier and HemoCue® HbA1c 501
|
1-1-2020
|
|
OSANG Healthcare Co.,Ltd
|
CLOVER A1c,CLOVER A1c Self and CHECKART
|
1-1-2020
|
|
OSANG Healthcare Co.,Ltd
|
CLOVER A1c Plus
|
1-1-2020
|
|
Polymer Technology Systems Inc (PTS Diagnostics)
|
A1cNow+, A1cNow SELF CHECK
|
1-1-2020
|
|
Polymer Technology Systems Inc (PTS Diagnostics)
|
Tosoh G8
|
1-1-2020
|
|
Roche Diagnostics
|
TQ HbA1c Gen. 3 (cobas c 501/502)
|
1-1-2020
|
|
Roche Diagnostics
|
TQ HbA1c Gen. 3 (cobas c 503)
|
1-1-2020
|
|
Roche Diagnostics
|
TQ HbA1c Gen. 3 (cobas c 513)
|
1-1-2020
|
|
Roche Diagnostics
|
TQ HbA1c Gen. 3 (COBAS INTEGRA 400 plus)
|
1-1-2020
|
|
Roche Diagnostics International Ltd
|
cobas HbA1c Test (cobas b 101)
|
1-1-2020
|
|
SEBIA
|
CAPILLARYS HbA1c
|
1-1-2020
|
|
SEBIA
|
CAPI3 HbA1c
|
1-1-2020
|
|
SEBIA
|
MINICAP HbA1c
|
1-1-2020
|
|
Sekisui Medical Co., Ltd.
|
Hemoglobin Analyzer RC-W (FAST mode)
|
1-1-2020
|
|
Sekisui Medical Co., Ltd.
|
Hemoglobin Analyzer RC-W (VARIANT mode)
|
1-1-2020
|
|
Shanghai Mecdonn Medical Technology CO., LTD.
|
MQ-2000PT
|
1-1-2020
|
|
Shanghai Medconn Biotechnology Co., Ltd.
|
AU5800(Latex agglutination)
|
1-1-2020
|
|
Shanghai Medconn Medical Technology CO., LTD
|
MQ-6000
|
1-1-2020
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
FA-160 Lateral Flow Immunoassay Analyzer/
Lateral Flow Immunoassay
|
1-1-2020
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
GH-900/GH-900Plus HbA1c Analyser/Ion-exchange HPLC
|
1-1-2020
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
H8 Hemoglobin Analyzer(HPLC)/Ion-exchange HPLC
|
1-1-2020
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
H9 Hemoglobin Analyzer(HPLC) /Ion-exchange HPLC
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS200 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS2000&BS2000M HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS200E HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS240 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS240Pro HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS300 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS330E HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS360E HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS380 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS400 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS460 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS480 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS600 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS800&BS800M HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS830 HbA1c
|
1-1-2020
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
H50 and H50P HbA1c
|
1-1-2020
|
|
Siemens Healthcare Diagnostics
|
DCA Vantage
|
1-1-2020
|
|
Siemens Healthcare Diagnostics Inc.
|
Dimension® clinical chemistry system A1C
|
1-1-2020
|
|
Siemens Healthcare Diagnostics Inc.
|
ADVIA Chemistry Enzymatic Hemoglobin A1c( A1c_E)
|
1-1-2020
|
|
Siemens Healthcare Diagnostics Inc.
|
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
|
1-1-2020
|
|
Siemens Healthcare Diagnostics Inc.
|
Dimension Vista® System A1C
|
1-1-2020
|
|
Skyla Corporation Hsinchu Science Park Branch
|
skyla Hi Analyzer
|
1-1-2020
|
|
Taidoc Technology Corporation
|
Immunoassay on TD-4611
|
1-1-2020
|
|
TASCOM Co., Ltd./R&D Center
|
SimplexTAS™ HbA1c
|
1-1-2020
|
|
Thermo Fisher Scientific Oy
|
IndikoTM/ 981947, 981948 HbA1c
|
1-1-2020
|
|
Thermo Fisher Scientific Oy
|
KonelabTM/ 981947, 981948 HbA1c
|
1-1-2020
|
|
Tosoh Corporation
|
ST AIA-PACK HbA1c
|
1-1-2020
|
|
Tosoh Corporation
|
HLC-723G11
|
1-1-2020
|
|
Tosoh Corporation
|
HLC-723G8
|
1-1-2020
|
|
Tosoh Corporation
|
HLC-723GX
|
1-1-2020
|
|
Trinity Biotech
|
PDQ
|
1-1-2020
|
|
Trinity Biotech
|
Premier Hb9210™
|
1-1-2020
|
|
Trinity Biotech
|
ultra2
|
1-1-2020
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd
|
A1C EZ 2.0 Glycohemoglobin Analysis System
|
1-1-2020
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd
|
A1cChek Express Glycohemoglobin Analysis System
|
1-1-2020
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd
|
A1cChek Pro Glycohemoglobin Analysis System
|
1-1-2020
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd
|
GluCoA1c Blood Glucose and Glycohemoglobin
Analysis System
|
1-1-2020
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd
|
HC-880 Automatic Glycohemoglobin Analysis System
|
1-1-2020
|
|
WELLS BIO, INC.
|
CareU Analyzer 100, careSURE Analyzer 100
|
1-12-2019
|
|
Maccura Biotechnology Co., Ltd.
|
maccura G 01
|
4-11-2019
|
|
iXensor Co., Ltd.
|
PixoTest POCT System
|
1-11-2019
|
|
Shenzhen Bioeasy Biotechnology Co.,Ltd.
|
EASY-11/Fluorescence Immunoassay
|
1-9-2019
|