|
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
|