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In vitro diagnostic medical devices
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Clinical chemistry
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Enzymes
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Enzymes - other
Enzymes - other
W01010199
229 devices
Devices
Adenosine Deaminase (Ada)
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
Glucose-6-Phosphate Dehydrogenase Controls
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
Adenosine Deaminase Test Kit (Rate Assay)
Shanghai Kehua Bio-engineering Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Glutathione Reductase Reagent Kit (Glutathione Substrate Assay)
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/MDR
α-L-Fucosidase Reagent Kit (CNPF Substrate Method)
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
Isocitrate Dehydrogenase Reagent Kit（the Substrate Method）
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
NEONATAL Total Galactose Screening Assay
Zentech s.a.
·
,
BE
IVD General
CE/IVDD
Adenosine Deaminase Kit (Enzymatic Colorimetric Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
Super Oxide Dismutase Reagent Kit (Pyrogallol Substrate Assay)
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
α-L-Fucosidase Kit (CNPF Method)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Super Oxide Dismutase Reagent Kit (Pyrogallol Substrate Assay)
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
Γ-Glutamyl Transferase Reagent Kit（ifcc Method）
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
Superoxide Dismutase(SOD) Assay Kit(Pyrogallol Method)
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
CN
IVD General
CE/IVDD
GSP Neonatal Biotinidase kit
Wallac Oy
·
,
FI
IVD General
FDA 510(k)
K131284
Active
Cleared 14 Nov 2013
CE/IVDD
α-L-Fucosidase Reagent Kit (CNPF Substrate Method)
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/MDR
Glutathione Reductase (GR) Assay Kit (Glutathione Substrate Method)
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
CN
IVD General
CE/IVDD
NEONATAL Total Galactose Screening Assay
Lacar MDX Technologies
·
,
BE
IVD General
CE/IVDD
EpiScreen Plus
FertiPro
·
,
BE
Class B
CE/IVDR
EpiScreen Plus Reagent 3
FertiPro
·
,
BE
Class B
CE/IVDR
Penase
Oxoid Ltd
·
,
GB
Class A
CE/IVDR
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