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Categories
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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 calibrators/controls
W01030207
232 devices
Subcategories
3
W0103020701
Calibration plasma for haemostasis
64
devices
W0103020702
Control plasma for haemostasis
141
devices
W0103020799
Haemostasis controls - other
27
devices
Devices
STA® - Dabigatran Calibrator
Diagnostica Stago
·
,
FR
Class C
CE/IVDR
Yumizen G CAL
Horiba Abx SAS
·
,
FR
Class C
CE/IVDR
HemosIL Heparin Calibrators
Instrumentation Laboratory Company
·
,
US
Class C
CE/IVDR
GUDID
on market
TriniCAL Fibrinogen
Tcoag ireland ltd
·
,
IE
IVD General
CE/IVDD
MRX Free Protein S Calibrator
Nordic Biomarker AB
·
,
SE
IVD General
CE/IVDD
HemosIL Calibration Plasma
Instrumentation Laboratory Company
·
,
US
Class C
FDA 510(k)
K041905
Active
Cleared 28 Sep 2004
CE/IVDR
+1
authorizations
Fibrinogen Standard
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
STA® - Edoxaban Calibrator
Diagnostica Stago
·
,
FR
Class C
CE/IVDR
MRX PT Quick (INR) Calibrator Set
Nordic Biomarker AB
·
,
SE
IVD General
CE/IVDD
D-Dimer Calibrator
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
D-Dimer Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
MRX D-dimer FEU Calibrator
Nordic Biomarker AB
·
,
SE
Class C
CE/IVDR
HemosIL Apixaban Calibrators
Instrumentation Laboratory Company
·
,
US
Class C
CE/IVDR
Coagulation Calibrator
Wiener Laboratorios SAIC
·
,
AR
IVD General
CE/IVDD
HemosIL Dabigatran Calibrators
Instrumentation Laboratory Company
·
,
US
Class C
CE/IVDR
D-Dimer Controls I / Ii
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
HEXAMATE Factor XIII - Calibrator
Medical & Biological Laboratories Co., Ltd.
·
,
JP
Class B
CE/IVDR
Yumizen G CTRL I & II
Horiba Abx SAS
·
,
FR
Class C
CE/IVDR
Antithrombin III Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
CRYOcheck
Precision Biologic Inc
·
,
CA
IVD General
CE/IVDD
GUDID
on market
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