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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
Haematology controls and calibrators
W01030105
636 devices
Subcategories
8
W0103010501
Normal blood controls
41
devices
W0103010502
Abnormal blood controls
27
devices
W0103010503
Multilevel blood controls
230
devices
W0103010504
Haemoglobin controls
48
devices
W0103010505
Platelet controls
13
devices
W0103010506
Reticulocyte controls
44
devices
W0103010507
Whole blood calibrators
80
devices
W0103010599
Haematology controls - other
153
devices
Devices
Hematology Control
Edan Instruments, Inc.
·
,
China
Class B
CE/IVDR
HbA1c Control Material
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
RESOLVE Hb FASC Control Kit
Wallac Oy
·
,
Finland
IVD General
CE/IVDD
GUDID
on market
CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution
GC MEDIS Corp.
·
,
South Korea
IVD Annex II List B
CE/IVDD
Hemonitor H1 Control Set
Genbody Inc.
·
,
South Korea
Class B
CE/IVDR
IX 2631406-1
Active
Valid to Oct 2030
Hemoglobin A2 elevated control
Seleo S.r.l.
·
,
Italy
IVD General
CE/IVDD
Hemoglobin control
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hemoglobin control
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hemoglobin control
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
CERA-CHEK™ Hb Plus Hemoglobin Control Solution
GC MEDIS Corp.
·
,
South Korea
IVD for self-testing
CE/IVDD
ß-THALASSAEMIA & HbA1c Control Material
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
AllDx
Hangzhou Aokai Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Plasma/Low Hb Control '5.0'
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
VALIDATE® HbA1c Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
VALIDATE® HbA1c Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HemoTrol High (Level 3)
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
HemoTrol Duo Low
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
HbDIL DxC
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
extendSURETM Haemoglobin F and A2 Calibrators
Canterbury Scientific, Ltd.
·
,
New Zealand
IVD General
CE/IVDD
GUDID
on market
Hb 301 Control Normal
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
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