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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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Control plasma for haemostasis
Control plasma for haemostasis
W0103020702
141 devices
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
HemosIL Low Abnormal Control Assayed
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
GUDID
on market
Coagulation control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HCY Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Fibrin(ogen) Degradation Products (FDP) 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
Coagulation Quality Control Plasma (CQC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HemosIL Normal Control Assayed
Instrumentation Laboratory Company
·
,
United States
Class C
FDA 510(k)
K021023
Active
Cleared 14 May 2002
CE/IVDR
+1
authorizations
TEControl A
TECO Medical Instruments, Production + Trading GmbH
·
,
Germany
IVD General
CE/IVDD
Unfractionated Heparin Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HemosIL CL Multi-Ab Controls
Instrumentation Laboratory Company
·
,
United States
Class B
CE/IVDR
GUDID
on market
Coagulation Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
APCr Controls
Pentapharm AG
·
,
Switzerland
IVD General
CE/IVDR
CE/IVDD
STA® - Routine QC 2 ml
Diagnostica Stago
·
,
France
Class C
CE/IVDR
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
Control Plasma Pathologic
Wiener Laboratorios SAIC
·
,
Argentina
IVD General
CE/IVDD
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