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In vitro diagnostic medical devices
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Haematology / haemostasis / immunohaematology / histology / cytology
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Haemostasis reagents (coagulation)
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General coagulation tests
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Prothrombin time ( quick test )
Prothrombin time ( quick test )
W0103020101
93 devices
Bio-Ksel PT plus
Bio-Ksel Sp. z o.o.
·
,
Poland
IVD General
CE/IVDD
Prothrombin Time Detection Kit (Coagulation Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Recoplastin ISI 1.0 PT Reagent
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
HemosIL ReadiPlasTin
Open recall
Instrumentation Laboratory Company
·
,
United States
Class C
FDA 510(k)
×2
K122584
Active
Cleared 24 Mar 2013
CE/IVDR
+1
authorizations
Prothrombin Time (PT) Assay Kit (Clotting Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
TEClot PT-S
TECO Medical Instruments, Production + Trading GmbH
·
,
Germany
IVD General
CE/IVDD
STA® - NeoPTimal 10
Diagnostica Stago
·
,
France
Class C
CE/IVDR
Prothrombin Time Assay Reagent (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Soluplastin
Wiener Laboratorios SAIC
·
,
Argentina
IVD General
CE/IVDD
Prothrombin Time
Medcaptain Medical Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
Prothrombin Time
Medcaptain Medical Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
HemosIL PT-Fibrinogen HS PLUS
Instrumentation Laboratory Company
·
,
United States
Class C
FDA 510(k)
K060931
Active
Cleared 2 May 2006
CE/IVDR
+1
authorizations
Prothrombin Time Assay Reagent (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
TT Thrombin Time Test Kit
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
China
IVD General
CE/IVDD
FIB Fibrinogen Test Kit
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
China
IVD General
CE/IVDD
Prothrombin Time (PT) Test Kit (Coagulation)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
PT Reagent ISI 1.5
Kalians Corporation
·
,
Egypt
IVD General
CE/IVDD
PT CoaguDx Test Strip
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
STA® - Hepato-Prest 10
Diagnostica Stago
·
,
France
Class C
CE/IVDR
Prothrombin Time Detection Kit (Coagulation Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
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