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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
Devices
5'-NT Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Pancreatic Amylase Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
MAS® ChemTRAK H Unassayed Control Sample Pack
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Adenosine Deaminase (ADA) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Enzyme Multical Control
Shanghai Kehua Bio-engineering Co., Ltd.
·
,
CN
IVD General
CE/IVDD
ACE Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
β-HB Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class B
CE/IVDR
MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
ADA Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
5′-Nucleotidase (5'-NT) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Enzyme compound quality control products
URIT Medical Electronic Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Cormay Ck-Mb Control N
PZ CORMAY Spółka Akcyjna
·
,
PL
IVD General
CE/IVDD
5′-Nucleotidase (5'-NT) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Ada Control
Medicon Hellas SA
·
,
GR
IVD General
CE/IVDD
5′-Nucleotidase (5'-NT) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/MDR
Adenosine Deaminase (ADA) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
5′-Nucleotidase (5'-NT) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
careSTART™ G6PD Biosensor Control Level I
Wells Bio, Inc.
·
,
KR
IVD General
CE/IVDD
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