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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
/
Monoclonal antibodies / flow cytometry
/
Monoclonal antibodies for cell surface antigens
/
Antibodies for lymphocyte subtyping
Antibodies for lymphocyte subtyping
W0103080106
19 devices
Devices
AQUIOS Tetra-2+ Panel
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
TBNK 4-color CD3/CD16+CD56/CD45/CD19 Kit
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody R…
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
Anti-Human CD3 Antibody
Chengdu Legend-Tec Technology Co., Ltd
·
,
CN
IVD General
CE/IVDD
AQUIOS Tetra-1 Panel
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
AQUIOS PLG Software
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
TBNK 4-color CD3/CD16+CD56/CD45/CD19 Kit
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/84-RD1
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Monoclonal Mouse Anti-Human CD127/PE, Clone A019D5
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
Monoclonal Mouse Anti-Human CD127/PE, Clone A019D5
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
Monoclonal Mouse Anti-Human CD69/PE, Clone FN50
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
HLA-B27 Kit
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class B
CE/IVDR
CYTO-STAT CD3(IgG1)-FITC/CD56-RD1
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
CYTO-STAT/COULTER CLONE CD3 (IgG1)-FITC/T8-RD1
Beckman Coulter, Inc.
·
,
US
IVD General
FDA 510(k)
K922744
Active
Cleared 5 Feb 1993
CE/IVDD
+1
authorizations
Monoclonal Mouse Anti-Human CD69/PE, Clone FN50
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
Visitect
AccuBio Limited
·
,
GB
IVD General
CE/IVDD
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