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In vitro diagnostic medical devices
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Haematology / haemostasis / immunohaematology / histology / cytology
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Haematology reagents
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Haematology controls and calibrators
Haematology controls and calibrators
W01030105
636 devices
Subcategories
8
W0103010501
Normal blood controls
41
devices
W0103010502
Abnormal blood controls
27
devices
W0103010503
Multilevel blood controls
230
devices
W0103010504
Haemoglobin controls
48
devices
W0103010505
Platelet controls
13
devices
W0103010506
Reticulocyte controls
44
devices
W0103010507
Whole blood calibrators
80
devices
W0103010599
Haematology controls - other
153
devices
Devices
R&D Retic-I
R&D Systems, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Streck
Streck
·
,
United States
Class B
CE/IVDR
GUDID
on market
Hematology Control
Edan Instruments, Inc.
·
,
China
Class B
CE/IVDD
CE/IVDR
BC-3D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
BC-6D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
BC-RET 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
BC-RET 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
B30 Hematology Controls
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
China
IVD General
CE/IVDD
BC-6D 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
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
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