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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
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Monoclonal antibodies / flow cytometry
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Flow cytometry controls
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Lymphocyte subtyping controls
Lymphocyte subtyping controls
W0103080403
13 devices
Devices
AQUIOS Immuno-Trol Low Cells
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
IMMUNO-TROL Low Cells
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
AQUIOS ImmunoTrol Cells (Tetra/PLG)
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
AQUIOS Immuno-Trol Cells
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
IMMUNO-TROL Low Cells
Beckman Coulter, Inc.
·
,
US
IVD General
FDA 510(k)
K013842
Active
Cleared 13 Dec 2001
CE/IVDR
+1
authorizations
ClearLLab Control Cells Normal
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
COULTER CYTO-TROL Control Cells Kit
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Leuko-Trol Platelet Control Cells
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
IMMUNO-TROL Cells
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
ClearLLab Control Cells Abnormal
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
IMMUNO-TROL Cells
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
AQUIOS Immuno-Trol Low Cells (Tetra/PLG)
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
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