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In vitro diagnostic medical devices
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Clinical chemistry
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Controls/standards/calibrators clinical chemistry
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Specific controls (clinical chemistry)
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Enzyme controls
Enzyme controls
W0101050201
53 devices
AFU Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
CK-NAC/CK-MB Control (Level 2), 1 x 2 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
careSTART™ G6PD Biosensor Control Level II
Wells Bio, Inc.
·
,
South Korea
IVD General
CE/IVDD
CK-NAC/CK-MB Control (level 1), 1 x 2 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
Ace Control
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
5′-Nucleotidase (5'-NT) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MAS® ChemTRAK H Liquid Assayed Chemistry Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Vaginitis Multitest Control
Shenzhen Reetoo Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Aldolase Level 3 Control (Als Control 3)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
ACE Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Ada 2 Control
Medicon Hellas SA
·
,
Greece
Class C
CE/IVDR
CK-MB Control
Thermo Fisher Scientific Oy
·
,
Finland
Class C
CE/IVDR
G6PD Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
5′-Nucleotidase (5'-NT) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
CK (NAC & MB) Control
Cypress Diagnostics
·
,
Belgium
IVD General
CE/IVDD
Cardiac Marker Control VS
Cliniqa Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Aldolase Level 2 Control (Als Control 2)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
5′-Nucleotidase (5'-NT) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
α-L-Fucosidase (AFU) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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