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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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Monoclonal antibodies for cell surface antigens
/
Antibodies for b and t-cell subtyping
Antibodies for b and t-cell subtyping
W0103080101
34 devices
ClearLLab Bcell tube
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
ClearLLab M2 Cell tube
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
AQUIOS PLG Panel 50 Test
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T4-RD1
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K922745
Active
Cleared 5 Feb 1993
CE/IVDD
+1
authorizations
Cyto-Stat/Coulter Clone T11-RD1/B4-Fitc
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
IOTest CD8-PC7
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
CD3 Fitc
Shenzhen Wellgrow Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDR
CE/IVDD
+1
authorizations
ClearLLab T Cell tube
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
GUDID
on market
CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K982166
Active
Cleared 5 Nov 1998
CE/IVDD
+1
authorizations
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