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In vitro diagnostic medical devices
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Clinical chemistry
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Controls/standards/calibrators clinical chemistry
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Specific controls (clinical chemistry)
Specific controls (clinical chemistry)
W01010502
498 devices
Subcategories
8
W0101050201
Enzyme controls
53
devices
W0101050202
Lipid controls
39
devices
W0101050203
Bilirubin controls
22
devices
W0101050204
Electrolyte controls
42
devices
W0101050205
Diabetes controls
87
devices
W0101050207
Urine controls
96
devices
W0101050208
Csf controls
6
devices
W0101050299
Specific controls (cc) - other
153
devices
Devices
Lipid Control - Level 2 (Lpd Control 2)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Lipid Control Serum
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
small dense LDL-Control Set
Denka Co., Ltd.
·
,
Japan
Class B
CE/IVDR
GUDID
on market
VALIDATE® LP Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
VALIDATE® LP2 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
VALIDATE® LP Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Bilirubin Kontrolle
Diaglobal GmbH
·
,
Germany
IVD General
CE/IVDD
MAS Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MAS® Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Ultimate-D Bilirubin Control Level 3
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MAS Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Ultimate-D Bilirubin Control Level 4
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MAS® Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Ultimate-D Bilirubin Control Level 1
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
Ultimate-D Bilirubin Control Level 2
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MAS® Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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