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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
General coagulation tests
W01030201
254 devices
Subcategories
5
W0103020101
Prothrombin time ( quick test )
93
devices
W0103020102
Activated partial thromboplastin time
69
devices
W0103020103
Thrombin time / reptilase / batroxobin time
34
devices
W0103020104
Activated clotting time
8
devices
W0103020199
General coagulation tests - other
50
devices
Devices
HemosIL APTT-SP
Instrumentation Laboratory Company
·
,
United States
Class C
CE/IVDR
GUDID
on market
APTT Reagent (SP-UNICELIN)
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
Pacific Hemostasis Thromboplastin-D
Open recall
Fisher Diagnostics A division of Fisher Scientific Company, LLC
·
,
United States
IVD General
FDA 510(k)
×2
K994100
Active
Cleared 18 Feb 2000
CE/IVDD
+1
authorizations
APTT ellagic
Wiener Laboratorios SAIC
·
,
Argentina
IVD General
CE/IVDD
APTT CoaguDx Test Strip
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
Pacific Hemostasis® APTT-XL
Fisher Diagnostics A division of Fisher Scientific Company, LLC
·
,
United States
IVD General
CE/IVDD
GUDID
on market
APTT CoaguDx Test Strip
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
TriniCLOT Automated aPTT 6 mL
Tcoag ireland ltd
·
,
Ireland
IVD General
CE/IVDD
sthemO CK Prest
Diagnostica Stago
·
,
France
Class C
CE/IVDR
Activated Partial Thromboplastin Time Assay Kit (Coagulation Method )
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Aptt
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
APTT CoaguDx Test Strip
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hemoscann®
Quimica Clinica Aplicada S.A.
·
,
Spain
IVD General
CE/IVDD
Calcium Chloride 0.025M
Biolabo
·
,
France
Class A
CE/IVDR
Activated Partial Thromboplastin Time Reagent Kit (Clotting)
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Activated Partial Thromboplastin Time (Aptt)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Mrx Aptt
Nordic Biomarker AB
·
,
Sweden
Class C
CE/IVDR
C.K. Prest® 5
Diagnostica Stago
·
,
France
IVD General
CE/IVDD
Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Thrombin Time Assay Reagent（Coagulation Method）
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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