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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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Coagulation factors
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Fibrinogen assays (factor I)
Fibrinogen assays (factor I)
W0103020201
68 devices
Fibrinogen (FIB) Kit (Immunoturbidimetric Method)
Zybio Inc.
·
,
China
IVD General
CE/IVDD
Fibrinogen (Fb)Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrinogen (Fb)Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrinogen-LS Clauss Clotting Time Method
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
HemosIL Fibrinogen-C XL
Instrumentation Laboratory Company
·
,
United States
Class B
FDA 510(k)
×2
K073367
Active
Cleared 27 Dec 2007
CE/IVDR
+1
authorizations
Fibrinogen (Fb)Test Kit (Immunoturbidimetric)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Pacific Hemostasis High Fibrinogen Control Plasma
Fisher Diagnostics A division of Fisher Scientific Company, LLC
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Fibrinogen Reagent Kit (Clotting)
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrinogen (Fib)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrinogen Assay Kit (Modified Clauss Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrinogen
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
Functional Fibrinogen Assay
Medcaptain Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fibrinogen (FIB) Assay Kit (Clotting Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Fibrinogen
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
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