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In vitro diagnostic medical devices
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Haematology / haemostasis / immunohaematology / histology / cytology
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Monoclonal antibodies / flow cytometry
Monoclonal antibodies / flow cytometry
W010308
858 devices
Subcategories
6
W01030801
Monoclonal antibodies for cell surface antigens
569
devices
›
W01030802
Monoclonal antibodies for cytoplasmatic antigens
80
devices
›
W01030803
Stem cell enumeration reagents
2
devices
W01030804
Flow cytometry controls
62
devices
›
W01030805
Auxiliary & supplemental reagents for flow cytometry
24
devices
›
W01030806
Other reagents for flow cytometry
121
devices
›
Devices
APC (675/633) Setup Kit
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
IsFlower QC Beads
Beijing Challen Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Flow Set Pro Fluorospheres
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
Flow Check Fluorospheres
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
spinit®
biosurfit SA
·
,
Portugal
IVD General
CE/IVDD
AQUIOS Immuno-Trol Low Cells
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
AQUIOS ImmunoTrol Cells (Tetra/PLG)
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
AQUIOS Immuno-Trol Cells
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
IMMUNO-TROL Low Cells
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K013842
Active
Cleared 13 Dec 2001
CE/IVDR
+2
authorizations
ClearLLab Control Cells Normal
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
COULTER CYTO-TROL Control Cells Kit
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Leuko-Trol Platelet Control Cells
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
IMMUNO-TROL Cells
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
ClearLLab Control Cells Abnormal
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
IMMUNO-TROL Cells
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
AQUIOS Immuno-Trol Low Cells (Tetra/PLG)
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
Stem-Trol Control Cells
Immunotech SAS
·
,
France
Class C
CE/IVDR
GUDID
on market
AQUIOS STEM CD34 Control Cells
Immunotech SAS
·
,
France
Class C
CE/IVDR
Flow-Count Fluorospheres
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
IgG1(mouse)-PE
Immunotech SAS
·
,
France
Class B
CE/IVDR
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