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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
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Flow cytometry controls
Flow cytometry controls
W01030804
62 devices
Subcategories
5
W0103080401
Setup beads
11
devices
W0103080402
Leucocyte controls
1
device
W0103080403
Lymphocyte subtyping controls
13
devices
W0103080404
Stem cell enumeration controls
2
devices
W0103080499
Flow cytometry controls - other
35
devices
Devices
Flow-Check Pro Fluorospheres
Beckman Coulter Ireland Inc.
·
,
IE
Class A
CE/IVDR
GUDID
on market
Flow-Set Fluorospheres
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Demagnetization Beads
Maccura Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
PC7 (770/488) Setup Kit
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
IMMUNO-BRITE Standards Kit
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
ClearLLab Compensation Beads
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
IsFlower QC Beads
Beijing Challen Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
APC (675/633) Setup Kit
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
IsFlower QC Beads
Beijing Challen Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Flow Set Pro Fluorospheres
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
Flow Check Fluorospheres
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
spinit®
biosurfit SA
·
,
PT
IVD General
CE/IVDD
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
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