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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
Haematology / cell counting
W020201
596 devices
Subcategories
3
W02020101
Automated 5 part differential hematology analysers
374
devices
›
W02020102
Limited panel cell counting analysers
145
devices
›
W02020199
Cell counting instruments - other
77
devices
Devices
COULTER DxH Retic Pack
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
HTI Detergent
High Technology Inc.
·
,
United States
Class A
CE/IVDR
DxH 500 Series Cleaner
Beckman Coulter Ireland Inc.
·
,
Ireland
Class A
CE/IVDR
GUDID
on market
Para 12 Plus
Streck
·
,
United States
Class B
CE/IVDR
GUDID
on market
DxH 500 Series Lyse
Beckman Coulter Ireland Inc.
·
,
Ireland
Class A
FDA 510(k)
K081822
Active
Cleared 21 Jan 2009
CE/IVDR
+1
authorizations
Intensive Wash Solution
Zhejiang Pushkang Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automatic Hematology Analyzer F-CC Cell Clean
Maccura Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
COULTER DxH Cell Lyse (1L)
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Automatic Hematology Analyzer F-SC Cleaning Fluid
Maccura Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
DxH ECO Diluent
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
DxH ECO Cell Lyse (1L)
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
DxH ECO Cell Lyse (5L)
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
HTI Enzymatic Cleaner Concentrate
High Technology Inc.
·
,
United States
Class A
CE/IVDR
COULTER DxH Cleaner
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Para 12 Plus
Streck
·
,
United States
Class B
CE/IVDR
GUDID
on market
HTI Cleaning Solution
High Technology Inc.
·
,
United States
Class A
CE/IVDR
miLab™ Cartridge BCM
Noul Co., Ltd.
·
,
South Korea
IVD General
CE/IVDD
Hematology Control
B&E Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Extended IPU
Sysmex Europe SE
·
,
Germany
Class A
CE/IVDR
HA2 Hematology Analyzer
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
·
,
Hungary
Class A
CE/IVDR
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