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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Cardiac markers
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High-sensitivity c-.reactive protein
High-sensitivity c-.reactive protein
W01021308
90 devices
high sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered Nephel…
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochro…
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hypersensitive C-reactive Protein (hs-CRP) Assay Kit (Nephelometry)
Shenzhen Reetoo Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Hypersensitive C-reactive Protein Detection Kit (Chemiluminescence Immunoassay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay )
Getein Biotech, Inc
·
,
China
IVD General
CE/IVDD
25Tests/Kit
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
high sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered Nephel…
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
High Sensitive C-Reactive Protein (hs-CRP) Test Kit (Immunofluorescence)
Genrui Biotech Inc.
·
,
China
IVD General
CE/IVDD
High Sensitivity C Reactive Protein+C Reactive Protein (hsCRP+CRP) Test
Beijing Jinwofu Bioengineering Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HS-CRP STAT (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
IMMAGE 800 Immunochemistry Systems CCRP High Sensitivity Cardiac C-Reactive Pro…
Beckman Coulter, Inc.
·
,
United States
Class C
FDA 510(k)
K071002
Active
Cleared 21 Jun 2007
CE/IVDR
+1
authorizations
C- reactive Protein Assay Kit (Fluorescence Immunoassay)
DiYaLab ZJG Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
High Sensitivity C-Reaction Protein（hs-CRP）Kit (Latex Particle-Enhanced Immunon…
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
AURYX 90 hs CRP Reagent Kit
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Full-Range C-Reactive Protein (fCRP) Assay Kit (Latex Immunoturbidimetric Metho…
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
China
IVD General
CE/IVDD
C-Reactive Protein Reagent (CRP 2 x 200)
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
High Sensitivity C-Reaction Protein（hs-CRP）Kit (Latex Particle-Enhanced Immunon…
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
high sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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