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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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Fibrinolysis
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D-dimer
D-dimer
W0103020503
242 devices
D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Omlipo D-Dimer Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
D-Dimer Calibrator
Biokit, S.A.
·
,
Spain
Class C
CE/IVDR
D-Dimer test (Chemiluminescence Immunoassay)
Beijing Hotgen Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
D-Dimer Quantitative Test Kit (Time-Resolved FIA)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer (DD) Rapid Test Device (Plasma)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Chemiluminescent Immunoassay Kit
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Sharay D-Dimer(CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HemosIL D-Dimer HS 500
Instrumentation Laboratory Company
·
,
United States
Class C
FDA 510(k)
×5
K151534
Active
Cleared 6 Jul 2015
CE/IVDR
+1
authorizations
D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)
Guangzhou Decheng Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-dimer Assay Kit (Lateral Flow Immunoassay)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Chemiluminescent Immunoassay Kit
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Assay Kit (Immunoturbidimetry)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Atlas D-Dimer Latex, 50 Tests
Atlas Medical GmbH
·
,
Germany
IVD General
CE/IVDD
D-Dimer Assay Kit (Immunoturbidimetry)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Rapid Test Device (Colloidal Gold)
Hangzhou Realy Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Assay kit Assay kit(Chemiluminescence Immunoassay Method）
Shenzhen Dake Medical Technology Co., Ltd
·
,
China
Class C
CE/IVDR
D-Dimer (DD) Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
TOP D-Dimer
VELLAP Diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
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