|
Organisation
|
Method
|
Certified
|
|
MEDISENSOR, 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
|
|
HORIBA, Ltd.
|
B-analyst HbA1c/B-analyst S1
|
1-10-2019
|
|
Shenzhen Bioeasy Biotechnology Co.,Ltd.
|
EASY-11/Fluorescence Immunoassay
|
1-9-2019
|
|
77 Elektronika Kft.
|
SmartTester
|
1-6-2019
|
|
Abbott Diagnostics Technologies AS
|
AFINION™ 2 / AFINION™ HbA1c Dx
|
1-6-2019
|
|
Abbott Diagnostics Technologies AS
|
Alere Afinion™ AS100 Analyzer / AFINION™ HbA1c Dx
|
1-6-2019
|
|
Abbott Diagnostics Technologies AS
|
NycoCard™ READER II / NycoCard™ HbA1c
|
1-6-2019
|
|
Abbott Diagnostics Technologies AS
|
AFINION™ 2 / AFINION™ HbA1c
|
1-6-2019
|
|
Abbott Diagnostics Technologies AS
|
Alere Afinion™ AS100 Analyzer / AFINION™ HbA1c
|
1-6-2019
|
|
biosurfit
|
spinit® HbA1c
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, BioMajesty JCA-BM6010/C
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, BX-3010
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, Hitachi 917
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
HbA1c net FS, respons®910
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 2 components, Hitachi 917
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 3 components, Hitachi 917
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c IS, InnovaStar
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 2 components, respons®910
|
1-6-2019
|
|
DiaSys Diagnostic Systems GmbH
|
oneHbA1c FS, 2 components, respons®920
|
1-6-2019
|
|
EKF Diagnostic GmbH
|
Quo-Lab HbA1c
|
1-6-2019
|
|
EKF Diagnostic GmbH
|
Quo-Test HbA1c
|
1-6-2019
|
|
HITADO GmbH
|
Super ID HbA1c
|
1-6-2019
|
|
Linear Chemicals S.L.U.
|
HbA1c - Turbidimetric
|
1-6-2019
|
|
Orion Diagnostica Oy
|
QuikRead go HbA1c
|
1-6-2019
|
|
Trinity Biotech
|
Tri-stat 1
|
1-6-2019
|
|
Trinity Biotech
|
Tri-stat 2
|
1-6-2019
|
|
Skyla Corporation H.S.P.B.
|
skyla Hi Analyzer
|
1-5-2019
|
|
LABNOVATION TECHNOLOGIES, INC.
|
POCT HbA1c Analyzer LD-100, LD-120 and LD-160
|
12-4-2019
|
|
SD Biosensor, Inc
|
STANDARD ™ F100
|
1-4-2019
|
|
SD Biosensor, Inc
|
STANDARD™ A1cCare
|
1-4-2019
|
|
SD Biosensor, Inc
|
STANDARD ™ F200
|
1-4-2019
|
|
SD Biosensor, Inc
|
STANDARD ™ F2400
|
1-4-2019
|
|
SD Biosensor, Inc
|
MultiCare™ System
|
1-4-2019
|
|
TASCOM Co., Ltd./R&D Center
|
SimplexTAS™ 101 HbA1c/Enzyme method
|
22-2-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - CinQ HbA1c
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8160
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8160TP
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY.Inc. - ADAMS A1c HA-8160VP
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8170
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8180
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8180T
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8180V Variant Mode
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8181
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8190V Fast Mode
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c HA-8190V Variant Mode
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c Lite HA-8380
|
1-1-2019
|
|
ARKRAY, Inc.
|
ARKRAY, Inc. - ADAMS A1c Lite HA-8380V Variant Mode
|
1-1-2019
|
|
Axis-Shield Diagnostics Ltd.
|
Abbott Architect
|
1-1-2019
|
|
Axis-Shield Diagnostics Ltd.
|
Axis-Shield Clinical Chemistry HbA1c Reagent Kit
|
1-1-2019
|
|
Bio-Rad Laboratories
|
D-10, Dual
|
1-1-2019
|
|
Bio-Rad Laboratories
|
D-10 HbA1c
|
1-1-2019
|
|
Bio-Rad Laboratories
|
D-100, HbA1c
|
1-1-2019
|
|
Bio-Rad Laboratories
|
Variant II Turbo HbA1c Kit- 2.0 (12000447)
|
1-1-2019
|
|
Bio-Rad Laboratories
|
Variant II, HbA1c Dual
|
1-1-2019
|
|
Bio-Rad Laboratories
|
Variant II, HbA1c Nu
|
1-1-2019
|
|
Bio-Rad Laboratories
|
Variant II Turbo, HbA1c
|
1-1-2019
|
|
Bio-Rad Laboratories
|
Variant II Turbo, HbA1c/2.0
|
1-1-2019
|
|
Bio-Rad Laboratories
|
D-10 Screening and Diagnosis Kit
|
1-1-2019
|
|
Diazyme Laboratories, Inc.
|
Diazyme Direct Enzymatic HbA1c Assay
|
1-1-2019
|
|
DxGen Corp.
|
Epithod®616 HbA1c Measuring System (Ep.616)
|
1-1-2019
|
|
Erba Lachema s.r.o.
|
ERBA Hb-Vario
|
1-1-2019
|
|
Erba Lachema s.r.o.
|
HbA1c Kit – XL-1000
|
1-1-2019
|
|
Erba Lachema s.r.o.
|
HbA1c Kit – XL-200/EM-200
|
1-1-2019
|
|
Erba Lachema s.r.o.
|
HbA1c Kit – XL-640
|
1-1-2019
|
|
Getein Biotech, Inc.
|
Colloidal Gold/FIA8000/8600
Quantitative Immunoassay Analyzer
|
1-1-2019
|
|
Getein Biotech, Inc.
|
Immunofluorescence Assay/Getein1100 Immunofluorescence Quantitative Analyzer
|
1-1-2019
|
|
Getein Biotech, Inc.
|
Immunofluorescence Assay/Getein1600 Immunofluorescence Quantitative Analyzer
|
1-1-2019
|
|
Getein Biotech, Inc.
|
Immunofluorescence Assay/Getein3200
Integrated System
|
1-1-2019
|
|
Green Cross Medical Science Corp.
|
GREENCARE A1c
|
1-1-2019
|
|
Green Cross Medical Science Corp.
|
QDx A1c Advance
|
1-1-2019
|
|
GREEN CROSS MEDIS Corp.
|
CERA-STAT 2000(Model: CS 2000) and QDX A1c
|
1-1-2019
|
|
GREEN CROSS MEDIS Corp.
|
CERA-STAT 4000(Model: CS 4000) and
Merilyzer MeriCheck A1c/CRP
|
1-1-2019
|
|
GREEN CROSS MEDIS Corp.
|
LabonaCheck A1c(Model: MH 200), A1c Card
|
1-1-2019
|
|
Guangzhou Wondfo Biotech Co., Ltd.
|
Finecare FIA Meter (Fluorescence Immunoassay)
|
1-1-2019
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 100/Immunoturbidimetric
|
1-1-2019
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 200/Immunoturbidimetric
|
1-1-2019
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 300SR/Immunoturbidimetric
|
1-1-2019
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaStar 600/Immunoturbidimetric
|
1-1-2019
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaMeter A1c/Boronate fluorescence quenching technology
|
1-1-2019
|
|
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
|
HumaNex A1c/HPLC
|
1-1-2019
|
|
i-SENS Inc.
|
A1Care
|
1-1-2019
|
|
JEOL Ltd.
|
JCA-BM 6010/C
|
1-1-2019
|
|
Jiangshan Derui Medical Science and Technology
Co., Ltd.
|
T10 HbA1c Analyzer
|
1-1-2019
|
|
Medtest
|
Bs480
|
1-1-2019
|
|
Medtest
|
Olympus
|
1-1-2019
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8160TP
|
1-1-2019
|
|
Menarini Diagnostics
|
Menarini Diagnostics - Menarini 8160VP
|
1-1-2019
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8180T
|
1-1-2019
|
|
Menarini Diagnostics
|
Menarini Diagnostics - ADAMS A1c HA-8180V Variant Mode
|
1-1-2019
|
|
OSANG Healthcare Co., Ltd
|
CLOVER A1c, CLOVER A1c Self and CHECKART
|
1-1-2019
|
|
OSANG Healthcare Co., Ltd
|
CLOVER A1c Plus
|
1-1-2019
|
|
OSANG Healthcare Co.,Ltd
|
Frontier and HemoCue® HbA1c 501
|
1-1-2019
|
|
Polymer Technology Systems Inc (PTS Diagnostics)
|
A1CNow+
|
1-1-2019
|
|
Polymer Technology Systems Inc (PTS Diagnostics)
|
Tosoh G8
|
1-1-2019
|
|
Roche Diagnostics
|
TQ HbA1c Gen.3 (cobas c 501/502)
|
1-1-2019
|
|
Roche Diagnostics
|
TQ HbA1c Gen.3 (cobas c 513)
|
1-1-2019
|
|
Roche Diagnostics
|
TQ HbA1c Gen.3 (COBAS INTEGRA 400 plus)
|
1-1-2019
|
|
SEBIA
|
CAPILLARYS HbA1c
|
1-1-2019
|
|
SEBIA
|
CAPI 3 HbA1c
|
1-1-2019
|
|
SEBIA
|
MINICAP HbA1c
|
1-1-2019
|
|
Shanghai Huizhong Medical Science and Technology
Co Ltd
|
MQ-2000PT
|
1-1-2019
|
|
Shanghai Huizhong Medical Science and Technology
Co Ltd
|
MQ-6000
|
1-1-2019
|
|
Shenzhen Labnovation Technologies, Inc.
|
Automated HbA1c Analyzer LD-500,LD-510 and LD-520 HPLC
|
1-1-2019
|
|
Shenzhen Labnovation Technologies, Inc.
|
Automated HbA1c Analyzer LD-600 and LD-620
HPLC
|
1-1-2019
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
FA-160 Lateral Flow Immunoassay Analyzer/
Lateral Flow Immunoassay
|
1-1-2019
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
GH-900 HbA1c Analyser/Ion-exchange HPLC
|
1-1-2019
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
H9 Hemoglobin Analyzer(HPLC) /Ion-exchange HPLC
|
1-1-2019
|
|
Shenzhen Lifotronic Technology Co.,Ltd
|
H8 Hemoglobin Analyzer(HPLC)/Ion-exchange HPLC
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co. Ltd
|
H50 and H50P HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS200 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS2000&BS2000M HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS200E HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS240 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS240Pro HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS300 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS330E HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS360E HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS380 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS400 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS460 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS480 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS600 HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS800&BS800M HbA1c
|
1-1-2019
|
|
Shenzhen Mindray Bio-Medical Electronics Co.Ltd
|
BS830 HbA1c
|
1-1-2019
|
|
Siemens Healthcare Diagnostics
|
DCA Vantage
|
1-1-2019
|
|
Siemens Healthcare Diagnostics Inc
|
Dimension ExL™/Hb1c
|
1-1-2019
|
|
Siemens Healthcare Diagnostics Inc
|
Dimension RxL®/Hb1c
|
1-1-2019
|
|
Siemens Healthcare Diagnostics Inc
|
Dimension Vista®/HbA1c
|
1-1-2019
|
|
Siemens Healthcare Diagnostics Inc.
|
ADVIA® Chemistry Systems/ Hemoglobin A1c_3
|
1-1-2019
|
|
Siemens Healthcare Diagnostics Inc.
|
Atellica CH/ Hemoglobin A1c_3
|
1-1-2019
|
|
Siemens Healthcare Diagnostics Inc.
|
ADVIA® Chemistry Systems/A1c_E
|
1-1-2019
|
|
TaiDoc Technology Corp.
|
Immunoassay on TD-4611
|
1-1-2019
|
|
Thermo Fisher Scientific Oy
|
Indiko™ Plus/ 981947,981948 HbA1c
|
1-1-2019
|
|
Thermo Fisher Scientific Oy
|
Konelab™ PRIME 60/ 981947,981948 HbA1c
|
1-1-2019
|
|
Tosoh Corporation
|
ST AIA-PACK HbA1c
|
1-1-2019
|
|
Tosoh Corporation
|
HLC-723 series
|
1-1-2019
|
|
Trinity Biotech
|
PDQ
|
1-1-2019
|
|
Trinity Biotech
|
Premier Hb9210
|
1-1-2019
|
|
Trinity Biotech
|
ultra2
|
1-1-2019
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd.
|
A1C EZ 2.0 Glycohemoglobin Analysis System
|
1-1-2019
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd.
|
A1cChek Express Glycohemoglobin Analysis System
|
1-1-2019
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd.
|
A1cChek Pro Glycohemoglobin Analysis System
|
1-1-2019
|
|
Wuxi Biohermes Bio&Medical Technology Co., Ltd.
|
GluCoA1c Blood Glucose and Glycohemolgobin Analysis System
|
1-1-2019
|
|
Roche Diagnostics International Ltd
|
cobas HbA1c Test (cobas b 101)
|
1-12-2018
|