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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
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
Hematology Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Control for Automatic Hematology Analyzer (5-part)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Hematology Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hematology Analyzer Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COULTER Body Fluid Control
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K082162
Active
Cleared 3 Feb 2009
CE/IVDD
+1
authorizations
Coulter Retic-C Cell Control
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Hematology Analyzer Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Latron Control 2
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Xn Check
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
Eightcheck-3WP
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
Eightcheck-3WP
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
Hematology Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
SYNCHRON Systems Ammonia/Alcohol Control Level 1
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Hematology Analyzer Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hematology Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Hematology Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Hema-Trol
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Xn Check Bf
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
Hematology Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Hematology Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
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