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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 b and t-cell subtyping
Antibodies for b and t-cell subtyping
W0103080101
34 devices
Devices
TrioTest CD4 FITC /CD8 PE/CD3 PerCP Kit
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
CD8-Ecd
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
ClearLLab LS Lymphoid Screen Reagent
Beckman Coulter India Private Limited
·
,
IN
Class C
CE/IVDR
ClearLLab M1 Cell tube
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
GUDID
on market
CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
AQUIOS PLG Panel 400 Test
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
TrioTest CD4 FITC /CD8 PE/CD3 PerCP Kit
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
QuadriTest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC Kit
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
QuadriTest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC Kit
Agilent Biosciences (Hangzhou) Co., Ltd.
·
,
CN
Class C
CE/IVDR
HLA-B27 Reagent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
ClearLLab Compensation Kit
Beckman Coulter India Private Limited
·
,
IN
Class C
CE/IVDR
Cyto-Stat/Coulter Clone T11-RD1/B1-Fitc
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Bd Multitest
Becton, Dickinson and Company, BD Biosciences
·
,
US
Class C
CE/IVDR
GUDID
on market
Bd Tritest
Becton, Dickinson and Company, BD Biosciences
·
,
US
Class C
CE/IVDR
CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
IVD General
CE/IVDD
Cyto-Stat Tirchrome CD45-FITC/CD8-RD1/CD3-PC5
Beckman Coulter, Inc.
·
,
US
IVD General
FDA 510(k)
K962305
Active
Cleared 6 Jan 1997
CE/IVDD
+1
authorizations
IOTest CD4-PC7
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
Cyto-Stat/Coulter Clone T8-RD1/T4-Fitc
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Cyto-Stat/Coulter Clone T4-RD1/T8-Fitc
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
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