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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
Devices
CreatineKinase-MB Controls
Accucise Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
Pathonorm® Cardiac Acute Liq L-2
Sero As
·
,
NO
IVD General
CE/IVDD
VivaDiag Creatine Kinase-MB Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
High Sensitivity Cardiac Troponin I Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
CreatineKinase-MB Controls
Accucise Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
VivaDiag Neutropil Gelatinase-associated Lipocalin Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Seronorm® Cardiac Acute Liq L-2
Sero As
·
,
NO
IVD General
CE/IVDD
VivaDiag N-terminal Pro-brain Natriuretic Peptide Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Cardiac Control - Level 1 (Crd Control 1)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
Lp-PLA2 Control
Medcaptain Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
VALIDATE® CM3 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
VALIDATE® CM1 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
NT-proBNP Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
NT-proBNP Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
Access BNP QC
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
Seronorm® Cardiac Acute Lyo L-3
Sero As
·
,
NO
IVD General
CE/IVDD
hs-cTnI Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
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