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In vitro diagnostic medical devices
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IVD instruments
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Hematology / histology / cytology instruments
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Haematology / cell counting
/
Automated 5 part differential hematology analysers
/
Automated whole blood hematology analysers - consumables
Automated whole blood hematology analysers - consumables
W0202010185
27 devices
Devices
Coulter DxH Diluent
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
DxH Concentrated ECO Diluent
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
Para 12 Plus
Streck
·
,
US
Class B
CE/IVDR
GUDID
on market
COULTER DxH Diff Pack
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
Coulter DxH Cell Lyse
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
COULTER DxH Cleaner
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
HTI Enzymatic Cleaner
High Technology Inc.
·
,
US
Class A
CE/IVDR
HTI Lytic
High Technology Inc.
·
,
US
Class A
CE/IVDR
Mythic 18-22 FLUSH - CLEANER
Orphée SA
·
,
CH
Class A
CE/IVDR
DxH 500 Series Diluent
Beckman Coulter Ireland Inc.
·
,
IE
Class A
CE/IVDR
GUDID
on market
HTI Diluent
High Technology Inc.
·
,
US
Class A
CE/IVDR
COULTER DxH Retic Pack
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
HTI Detergent
High Technology Inc.
·
,
US
Class A
CE/IVDR
DxH 500 Series Cleaner
Beckman Coulter Ireland Inc.
·
,
IE
Class A
CE/IVDR
GUDID
on market
Para 12 Plus
Streck
·
,
US
Class B
CE/IVDR
GUDID
on market
DxH 500 Series Lyse
Beckman Coulter Ireland Inc.
·
,
IE
Class A
FDA 510(k)
K081822
Active
Cleared 21 Jan 2009
CE/IVDD
+2
authorizations
Intensive Wash Solution
Zhejiang Pushkang Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Automatic Hematology Analyzer F-CC Cell Clean
Maccura Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
COULTER DxH Cell Lyse (1L)
Beckman Coulter, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
Automatic Hematology Analyzer F-SC Cleaning Fluid
Maccura Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
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