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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
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® - Quality HBPM/LMWH
Diagnostica Stago
·
,
France
Class C
CE/IVDR
GUDID
on market
Fibrin and Fibrinogen Degradation Products Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HemosIL D-Dimer Controls
Instrumentation Laboratory Company
·
,
United States
Class C
FDA 510(k)
×2
K050278
Active
Cleared 10 Mar 2005
CE/IVDR
HemosIL Plasma Coagulation Control Level I
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
Fibrin and Fibrinogen Degradation Products Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Coagulation Quality Control Plasma (CQC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
STA® - Apixaban Control
Diagnostica Stago
·
,
France
Class C
CE/IVDR
Fibrin and Fibrinogen Degradation Products Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Plasma Control Normal
Wiener Laboratorios SAIC
·
,
Argentina
IVD General
CE/IVDD
Fibrin and Fibrinogen Degradation Products Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Antithrombin Ⅲ (AT Ⅲ) Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Coagulation Quality Control Plasma (CQC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
TriniCHECK Control 2 (Assayed)
Tcoag ireland ltd
·
,
Ireland
IVD General
CE/IVDD
MRX Routine Abnormal Control
Nordic Biomarker AB
·
,
Sweden
Class C
CE/IVDR
Coagulation Quality Control Plasma (CQC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
sthemO FVII QC
Diagnostica Stago
·
,
France
Class B
CE/IVDR
sthemO Complete QC 1&2
Diagnostica Stago
·
,
France
Class C
CE/IVDR
HemosIL High Abnormal Control Assayed
Instrumentation Laboratory Company
·
,
United States
Class C
FDA 510(k)
K021024
Active
Cleared 16 May 2002
CE/IVDR
+1
authorizations
Lupus Anticoagulant Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
microINR EasyControl
Iline Microsystems, S.L.
·
,
Spain
IVD General
CE/IVDD
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