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In vitro diagnostic medical devices
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Enzymes - other
Enzymes - other
W01010199
229 devices
Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay )
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Enzymatic Creatinine
Beckman Coulter Ireland Inc.
·
,
Ireland
Class B
CE/IVDR
Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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
Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay )
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Glutathione Reductase Reagent Kit (Glutathione Substrate Assay)
Dirui Industrial 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
NEONATAL MSUD Screening Assay
Zentech s.a.
·
,
Belgium
IVD General
CE/IVDD
Γ-Glutamyl Transferase Reagent Kit（ifcc Method）
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
NEONATAL Biotinidase Screening Assay
Lacar MDX Technologies
·
,
Belgium
IVD General
CE/IVDD
Adenosine Deaminase Reagent Kit（enzyme Method）
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
α-L-Fucosidase Reagent Kit (CNPF Substrate Method)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Neonatal Biotinidase
Labsystems Diagnostics Oy
·
,
Finland
IVD General
CE/IVDD
Neonatal Total Galactose kit
Wallac Oy
·
,
Finland
IVD General
FDA 510(k)
K071649
Active
Cleared 7 Aug 2008
CE/IVDD
+1
authorizations
Mitochondrial Aspartate Aminotransferase Kit (Immunosuppression Method)
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Adenosine Deaminase (ADA) Assay Kit (Enzymatic Colorimetric Method)
Yhlo Biotech (Nanjing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Ada
Medicon Hellas SA
·
,
Greece
Class C
CE/IVDR
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