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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Controls - immunochemistry
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Cardiac marker controls
Cardiac marker controls
W0102152004
177 devices
VALIDATE® CM2 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Seronorm® Cardiac Acute Liq L-3
Sero As
·
,
Norway
IVD General
CE/IVDD
Finecare
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
hs-cTnI Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
NT-proBNP Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
hs-cTnI Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
VALIDATE® CM2 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CLIA NT-proBNP Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
BNP Control
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Lp-PLA2 Control Bi-Level
Techno-Path Manufacturing
·
,
Ireland
IVD General
CE/IVDD
sST2 Controls
Accucise Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
CK & CK-MB Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
hs-cTnT Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Seronorm® Cardiac Acute Liq L-1B
Sero As
·
,
Norway
IVD General
CE/IVDD
Cardiac Combo (cTnI/CK-MB) Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
cTnI Control
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Finecare
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Pathonorm® Cardiac Acute Liq L-1
Sero As
·
,
Norway
IVD General
CE/IVDD
VALIDATE® CM1 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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