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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)
/
Haemostasis calibrators/controls
/
Control plasma for haemostasis
Control plasma for haemostasis
W0103020702
141 devices
HemosIL Special Test Control Level 1
Instrumentation Laboratory Company
·
,
United States
Class B
CE/IVDR
GUDID
on market
TriniCHECK D-Dimer 2
Tcoag ireland ltd
·
,
Ireland
IVD General
CE/IVDD
D-Dimer Control High
Thermo Fisher Scientific Oy
·
,
Finland
Class C
CE/IVDR
sthemO PS VWF QC 1&2
Diagnostica Stago
·
,
France
Class B
CE/IVDR
TEControl N
TECO Medical Instruments, Production + Trading GmbH
·
,
Germany
IVD General
CE/IVDD
Control Level 1
Nordic Biomarker AB
·
,
Sweden
Class C
CE/IVDR
HemosIL LA Positive Control
Instrumentation Laboratory Company
·
,
United States
Class B
FDA 510(k)
K102552
Active
Cleared 5 Apr 2011
CE/IVDR
+1
authorizations
HemosIL Apixaban Controls
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
Antithrombin III Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrin and Fibrinogen Degradation Products Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Control Level 2
Nordic Biomarker AB
·
,
Sweden
Class C
CE/IVDR
HemosIL Special Test Control Level 2
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
GUDID
on market
Lupus Anticoagulant Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HemosIL Rivaroxaban Controls
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
TriniCHECK Control 1 (Assayed)
Tcoag ireland ltd
·
,
Ireland
IVD General
CE/IVDD
Control Plasma Normal
Wiener Laboratorios SAIC
·
,
Argentina
IVD General
CE/IVDD
Lupus Anticoagulants Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
QC1
APIRO Diagnostics Kft.
·
,
Hungary
Class C
CE/IVDR
2025-IVDR/QS-007/A
Active
Valid to Oct 2030
HemosIL Dabigatran Controls
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
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