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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
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Haemostasis reagents (coagulation)
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Haemostasis calibrators/controls
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Calibration plasma for haemostasis
Calibration plasma for haemostasis
W0103020701
64 devices
Fibrin and Fibrinogen Degradation Products Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
TECal DD
TECO Medical Instruments, Production + Trading GmbH
·
,
Germany
IVD General
CE/IVDD
TriniCAL Reference Plasma
Tcoag ireland ltd
·
,
Ireland
IVD General
CE/IVDD
Fibrinogen Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Calibrator
Nordic Biomarker AB
·
,
Sweden
Class C
CE/IVDR
sthemO Heparin cal
Diagnostica Stago
·
,
France
Class C
CE/IVDR
MRX FDP Clear Calibrator Set
Nordic Biomarker AB
·
,
Sweden
IVD General
CE/IVDD
D-Dimer Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrinogen Degradation Product (FDP) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
sthemO FDP cal
Diagnostica Stago
·
,
France
Class B
CE/IVDR
Calibrator Fibr/PT
Cypress Diagnostics
·
,
Belgium
IVD General
CE/IVDD
STA® - FM Calibrator
Diagnostica Stago
·
,
France
Class B
CE/IVDR
D-Dimer Calibration Set
Thermo Fisher Scientific Oy
·
,
Finland
Class C
CE/IVDR
Fibrin and Fibrinogen Degradation Products Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HemosIL Rivaroxaban Calibrators
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
HemosIL ISI Calibrate
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
GUDID
on market
Coagulation calibrator
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
D-Dimer Standard
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
HEXAMATE Factor XIII – Control I/II
Medical & Biological Laboratories Co., Ltd.
·
,
Japan
Class B
CE/IVDR
D-Dimer Calibrators
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
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