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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry controls/standards/calibrators
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Standards and calibrators immunochemistry
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Tdm/drug standards and calibrators
Tdm/drug standards and calibrators
W0102152201
25 devices
Devices
Voriconazole Control
Jiangxi Medicalsystem Biological Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Clozapine Reagent Set
Diagnotix B.V.
·
,
NL
IVD General
CE/IVDD
Nortriptyline Reagent Set
Diagnotix B.V.
·
,
NL
IVD General
CE/IVDD
Immune Inhibitor Control
Jiangxi Medicalsystem Biological Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
SYNCHRON Systems Vancomycin Calibrator
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
DAU Negative Calibrator
Beckman Coulter Ireland Inc.
·
,
IE
Class B
CE/IVDR
Emit 2000 Mycophenolic Acid Controls
Siemens Healthcare Diagnostics
·
,
US
Class C
CE/IVDR
SYNCHRON Systems Drug Calibrator 1
Beckman Coulter, Inc.
·
,
US
IVD General
FDA 510(k)
K993473
Active
Cleared 26 Nov 1999
CE/IVDD
+1
authorizations
DAU Intermediate Multi-Drug Calibrator
Beckman Coulter Ireland Inc.
·
,
IE
Class B
CE/IVDR
Alinity c Tox Qual Calibrators
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
Psychotropic Medication 3 Reagent Set
Diagnotix B.V.
·
,
NL
IVD General
CE/IVDD
Alinity c Tox SemiQuant Calibrators
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
Benzodiazepines Reagent Set
Diagnotix B.V.
·
,
NL
IVD General
CE/IVDD
DAU High Multi-Drug Calibrator
Beckman Coulter Ireland Inc.
·
,
IE
Class B
CE/IVDR
Emit 2000 Mycophenolic Acid Calibrators
Siemens Healthcare Diagnostics Products Limited
·
,
GB
Class C
CE/IVDR
Alinity c Tox Controls
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
Ethanol Calibrator
Medicon Hellas SA
·
,
GR
IVD General
CE/IVDD
Antimycotic Medication Reagent Set
Diagnotix B.V.
·
,
NL
IVD General
CE/IVDD
DAU Secondary cut-off Multi-Drug Calibrator
Beckman Coulter Ireland Inc.
·
,
IE
Class B
CE/IVDR
Psychotropic Medication 2 Reagent Set
Diagnotix B.V.
·
,
NL
IVD General
CE/IVDD
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