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In vitro diagnostic medical devices
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Reagents
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Clinical chemistry
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Enzymes
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Enzymes - other
Enzymes - other
W01010199
229 devices
Γ-Glutamyl Transferase Reagent Kit（ifcc Method）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Neonatal GALT
Wallac Oy
·
,
Finland
IVD General
CE/IVDD
GUDID
on market
NEONATAL MSUD Screening Fluo
Lacar MDX Technologies
·
,
Belgium
IVD General
CE/IVDD
Glucose-6-Phosphate Dehydrogenase (G6PD) Kit (UV Enzymatic Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Superoxide Dismutase (SOD) Kit (Colorimetric Method)
Zybio Inc.
·
,
China
IVD General
CE/IVDD
EpiScreen Plus Reagent 6
FertiPro
·
,
Belgium
Class B
CE/IVDR
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
BIOSYNEX AMPLIQUICK Lysis
Biosynex
·
,
France
Class A
CE/IVDR
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
NEONATAL T-GAL Screening Fluo
Zentech s.a.
·
,
Belgium
IVD General
CE/IVDD
NEONATAL T-GAL Screening Fluo
Lacar MDX Technologies
·
,
Belgium
IVD General
CE/IVDR
CE/IVDD
NEONATAL G-6-PD Screening Assay
Zentech s.a.
·
,
Belgium
IVD General
CE/IVDD
NEONATAL G-6-PD Screening Fluo
Lacar MDX Technologies
·
,
Belgium
IVD General
CE/IVDD
Monoamine Oxidase (MAO) Test Kit (Continuous Monitoring Method)
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Adenosine Deaminase (ADA) Assay Kit by Enzymatic Method
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Urine Leukocyte Esterase Test Kit
Zhejiang Pushkang Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
N-Acetyl-Β-D-Glucosaminidase Reagent Kit (Mpt-Nag Method)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Adenosine Deaminase Reagent Kit（enzyme Method）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
GSP Neonatal GALT kit
Wallac Oy
·
,
Finland
IVD General
CE/IVDD
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