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In vitro diagnostic medical devices
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Haematology / haemostasis / immunohaematology / histology / cytology
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Haematology reagents
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Haematology controls and calibrators
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Haemoglobin controls
Haemoglobin controls
W0103010504
48 devices
Devices
HbA1c Control Material
Shenzhen Lifotronic Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
RESOLVE Hb FASC Control Kit
Wallac Oy
·
,
FI
IVD General
CE/IVDD
GUDID
on market
CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution
GC MEDIS Corp.
·
,
KR
IVD Annex II List B
CE/IVDD
Hemonitor H1 Control Set
Genbody Inc.
·
,
KR
Class B
CE/IVDR
IX 2631406-1
Active
Valid to Oct 2030
Hemoglobin A2 elevated control
Seleo S.r.l.
·
,
IT
IVD General
CE/IVDD
Hemoglobin control
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
CN
IVD General
CE/MDR
Hemoglobin control
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Hemoglobin control
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
CERA-CHEK™ Hb Plus Hemoglobin Control Solution
GC MEDIS Corp.
·
,
KR
IVD for self-testing
CE/IVDD
ß-THALASSAEMIA & HbA1c Control Material
Shenzhen Lifotronic Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
AllDx
Hangzhou Aokai Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Plasma/Low Hb Control '5.0'
Eurotrol B.V.
·
,
NL
IVD General
CE/IVDD
VALIDATE® HbA1c Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
VALIDATE® HbA1c Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
HemoTrol High (Level 3)
Eurotrol B.V.
·
,
NL
IVD General
CE/IVDD
HemoTrol Duo Low
Eurotrol B.V.
·
,
NL
IVD General
CE/IVDD
HbDIL DxC
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
extendSURETM Haemoglobin F and A2 Calibrators
Canterbury Scientific, Ltd.
·
,
NZ
IVD General
CE/IVDD
GUDID
on market
Hb 301 Control Normal
Eurotrol B.V.
·
,
NL
IVD General
CE/IVDD
Hb 301 Control Low
Eurotrol B.V.
·
,
NL
IVD General
CE/IVDD
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