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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
STA® - Dabigatran Calibrator
Diagnostica Stago
·
,
France
Class C
CE/IVDR
Yumizen G CAL
Horiba Abx
·
,
France
Class C
CE/IVDR
HemosIL Heparin Calibrators
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
GUDID
on market
TriniCAL Fibrinogen
Tcoag ireland ltd
·
,
Ireland
IVD General
CE/IVDD
MRX Free Protein S Calibrator
Nordic Biomarker AB
·
,
Sweden
IVD General
CE/IVDD
HemosIL Calibration Plasma
Instrumentation Laboratory Company
·
,
United States
Class C
FDA 510(k)
K041905
Active
Cleared 28 Sep 2004
CE/IVDR
+1
authorizations
Fibrinogen Standard
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
STA® - Edoxaban Calibrator
Diagnostica Stago
·
,
France
Class C
CE/IVDR
MRX PT Quick (INR) Calibrator Set
Nordic Biomarker AB
·
,
Sweden
IVD General
CE/IVDD
D-Dimer Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MRX D-dimer FEU Calibrator
Nordic Biomarker AB
·
,
Sweden
Class C
CE/IVDR
HemosIL Apixaban Calibrators
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
Coagulation Calibrator
Wiener Laboratorios SAIC
·
,
Argentina
IVD General
CE/IVDD
HemosIL Dabigatran Calibrators
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
D-Dimer Controls I / Ii
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
HEXAMATE Factor XIII - Calibrator
Medical & Biological Laboratories Co., Ltd.
·
,
Japan
Class B
CE/IVDR
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