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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
/
Haemostasis reagents (coagulation)
/
Haemostasis calibrators/controls
/
Haemostasis controls - other
Haemostasis controls - other
W0103020799
27 devices
Devices
VALIDATE® HEPARIN Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
MRX FDP Clear Low Control
Nordic Biomarker AB
·
,
SE
IVD General
CE/IVDD
Dabigatran Controls
Siemens Healthcare Diagnostics Products GmbH
·
,
DE
Class C
CE/IVDR
VALIDATE® D-DIMER Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
CoaguDx Quality Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
CN
IVD General
CE/MDR
STA® - D-Di Control
Diagnostica Stago
·
,
FR
Class C
CE/IVDR
CoaguDx Quality Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
CN
IVD General
CE/IVDD
VALIDATE® FIBRINOGEN Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
CoaguDx Quality Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
CN
IVD General
CE/MDR
D-Dimer Calibrator
Darui Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
VALIDATE® HEPARIN Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Thromboelastography Control
Medcaptain Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
MRX FDP Clear High Control
Nordic Biomarker AB
·
,
SE
IVD General
CE/IVDD
Thromboelastography Reagent Control
Medcaptain Medical Technology Co., Ltd.
·
,
CN
Class C
CE/IVDR
VALIDATE® FIBRINOGEN Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
CoaguDx Quality Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
CN
IVD General
CE/IVDD
VALIDATE® D-DIMER Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
VALIDATE® HEPARIN Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
D-Dimer & FDP Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
VALIDATE® FIBRINOGEN Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
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