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In vitro diagnostic medical devices
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Enzymes
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Enzymes - other
Enzymes - other
W01010199
229 devices
EpiScreen Plus Reagent 2
FertiPro
·
,
Belgium
Class B
CE/IVDR
Afu
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
IDK® PMN-Elastase ELISA
Immundiagnostik AG
·
,
Germany
IVD General
CE/IVDD
GSP Neonatal G6PD kit
Wallac Oy
·
,
Finland
IVD General
CE/IVDD
N-Acetyl-Β-D-Glucosaminidase Reagent Kit (Mpt-Nag Method)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Neonatal G-6-PD Screening Assay
Lacar MDX Technologies
·
,
Belgium
IVD General
CE/IVDD
Superoxide Dismutase Kit (Colorimetric Method)
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
α-L-Fucosidase Kit (CNPF Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Α-Amylase
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Γ-Glutamyl Transferase Reagent Kit（ifcc Method）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Monoamine Oxidase Kit (Kinetic Method)
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method)
Biobase Biodustry(Shandong) 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
Alpha-L-Fucosidase (AFU) Test Kit (CNPF Substrate Method)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
EpiScreen Plus Reagent 5
FertiPro
·
,
Belgium
Class B
CE/IVDR
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