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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
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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