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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry controls/standards/calibrators
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Controls - immunochemistry
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Cardiac marker controls
Cardiac marker controls
W0102152004
177 devices
CK-MB Control
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
cTnT Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
VALIDATE® HS Troponin Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MAS® CardioImmune Ultra Low Control (6 x 3 mL)
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Seronorm® Cardiac Acute Lyo L-2
Sero As
·
,
Norway
IVD General
CE/IVDD
hs-cTnI Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Cardiac Combo (cTnI/NT-proBNP) Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myoglobin Controls
Accucise Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Myo Control
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
sST2 Control
Medcaptain Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
CK & CK-MB Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cardiac Markers Plus Control
Shanghai Kehua Bio-engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
D-dimer Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Cardiac Marker Control FD Level 1&2
NanoEnTek, Inc.
·
,
South Korea
IVD General
CE/IVDD
NT-proBNP Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
CLIA CK-MB Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cardiac Control – Level 2 (Crd Control 2)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Cardiac Markers Control Plus
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
NT-proBNP Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Cardiac Markers Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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