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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
/
Haematology reagents
/
Haematology controls and calibrators
/
Haematology controls - other
Haematology controls - other
W0103010599
153 devices
Quality Control for Hematology Analyzer
Hunan Ehome Health Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
SYNCHRON Systems Ammonia/Alcohol Control Level 2
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
COULTER 4C-ES Cell Control
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ABX Minotrol CRP
Horiba Abx
·
,
France
Class B
CE/IVDR
sthemA CTR-L2
Diagnostica Stago
·
,
France
Class B
CE/IVDR
Coagulation Calibrator
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Control for Hematology Analyzer
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Control for Hematology Analyzer
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Kemilo D-Dimer Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Coagulation Control I/Ii
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Xn-L Check
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
Xn Check Bf
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
Hematology Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Eightcheck-3WP
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
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
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