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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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Haematology reagents
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Haematology controls and calibrators
/
Multilevel blood controls
Multilevel blood controls
W0103010503
230 devices
BC-3D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
BC-3D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
BR60 Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
IVD General
CE/IVDD
BC-3D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Body Fluid-I
R&D Systems, Inc.
·
,
United States
IVD General
CE/IVDD
Myt-5D
Orphée SA
·
,
Switzerland
IVD General
CE/IVDD
BC-BF Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Coulter 5C Cell Control
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K060464
Active
Cleared 28 Mar 2006
CE/IVDD
+1
authorizations
R&D Retic-I
R&D Systems, Inc.
·
,
United States
Class B
CE/IVDR
B55 Hematology Controls
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hematology Control+crp Mk-3CN
Nihon Kohden Corporation
·
,
Japan
Class B
CE/IVDR
BC-6D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
BC-BF Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Body Fluid-I
R&D Systems, Inc.
·
,
United States
IVD General
CE/IVDD
Streck
Streck
·
,
United States
Class B
CE/IVDR
GUDID
on market
ABX Difftrol
Horiba Abx
·
,
France
Class B
CE/IVDR
BC-6D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
BC-BF Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
BC-BF Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
ABX Difftrol
Horiba Abx
·
,
France
Class B
CE/IVDR
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