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In vitro diagnostic medical devices
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Reagents
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Immunochemistry (immunology)
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Cardiac markers
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Cardiac markers - other
Cardiac markers - other
W01021399
50 devices
Ischemic Modified Albumin Reagent Kit (ACB Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
cTnI/CK-MB/Myo Rapid Quantitative Test
Coei Biotech Co.Ltd.
·
,
China
IVD General
CE/IVDD
sST2（CLIA）
Medcaptain Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Homoarginin ELISA
Immundiagnostik AG
·
,
Germany
IVD General
CE/IVDD
D-Dimer/cTnI/NT-proBNP Quantitative Test Kit (Time-Resolved FIA)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
D-Dimer Assay Kit（Fluorescence Immunoassay）
DiYaLab ZJG Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
ST2 Fast Test Kit (Immunofluorescence Assay)
Getein Biotech, Inc
·
,
China
IVD General
CE/IVDD
Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）
Shenzhen Dake Medical Technology Co., Ltd
·
,
China
Class C
CE/IVDR
Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Magicl ST2 (Clia)
Getein Biotech, Inc
·
,
China
IVD General
CE/IVDD
Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoas…
DiYaLab ZJG Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
hs cTnI /CK-MB/MyoRapid Test Kit (Quantum Dot Fluorescence Immunoassay)
Nanjing Synthgene Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Creatine Kinase-MB / High-sensitivity Cardiac Troponin I / Myoglobin ( CK-MB/Hs…
Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-Dimer Test Kit (Immunofluorescence)
Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Ischemic Modified Albumin Reagent Kit (ACB Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step CK MB/Myoglobin/ Troponin I Combo Test
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）
Shenzhen Dake Medical Technology Co., Ltd
·
,
China
Class C
CE/IVDR
Adma Elisa
Immundiagnostik AG
·
,
Germany
IVD General
CE/IVDD
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