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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
Hb 301 Control Low
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
ß-THALASSAEMIA & HbA1c Control Material
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
VALIDATE® HbA1c Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HemoTrol Duo High
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
extendSURE™ Haemoglobin F and A2 Controls
Canterbury Scientific, Ltd.
·
,
New Zealand
IVD General
CE/IVDD
GUDID
on market
HbA2 & HbF & HbA1c Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Hb 301 Control High
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
HemoTrol Duo Normal
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
HemoTrol High (Level 3)
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
HemoTrol Low (Level 1)
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
Plasma/Low Hb Control '1.0'
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
Hemoglobin Monitoring control solution
Sejoy Biomedical Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Hemoglobin A2 normal control
Seleo S.r.l.
·
,
Italy
IVD General
CE/IVDD
HemoTrol Normal (Level 2)
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
Sulfolyser
Sysmex Corporation
·
,
Japan
Class A
CE/IVDR
ß-THALASSAEMIA & HbA1c Control Material
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
Class C
CE/IVDD
CE/IVDR
AFSC Haemoglobin control
Seleo S.r.l.
·
,
Italy
IVD General
CE/IVDD
HbA1c Control Material
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Glycated hemoglobin quality control
B&E Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Plasma/Low Hb Control '20.0'
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
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