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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
Devices
Hematology Control
Wheisman Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
B30 Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class B
CE/IVDD
CE/IVDR
Hematology Control+crp Mk-3CL
Nihon Kohden Corporation
·
,
JP
Class B
CE/IVDR
Coulter 5C Cell Control
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Coulter 5C Cell Control
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
HEMATOLOGY CONTROL for reticulocyte MK-RE2
Nihon Kohden Corporation
·
,
JP
Class B
CE/IVDR
Hematology Control
Edan Instruments, Inc.
·
,
CN
IVD General
CE/IVDR
CE/IVDD
BC-6D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class B
CE/MDR
Hematology Control
Shenzhen Reetoo Biotechnology Co., Ltd
·
,
CN
IVD General
CE/IVDD
Hematology Control+crp Mk-3CH
Nihon Kohden Corporation
·
,
JP
Class B
CE/IVDR
SEDRite Plus Hematology Control
R&D Systems, Inc.
·
,
US
IVD General
CE/IVDD
Streck
Streck
·
,
US
Class B
CE/IVDR
GUDID
on market
COULTER 6C Plus Cell Control
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDR
CE/IVDD
+1
authorizations
BC-BF Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
Haematology Control - Level 1, 2, 3 (Haem Cntl - Level 1 +2 more)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
GUDID
on market
BC-BF Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
BC-3D Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class B
CE/MDR
BC-RET Hematology Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
ABX Minotrol 16
Horiba Abx SAS
·
,
FR
Class B
CE/IVDR
R&D Retic-I
R&D Systems, Inc.
·
,
US
Class B
CE/IVDR
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