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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)
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Bilirubin controls
Bilirubin controls
W0101050203
22 devices
Devices
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Bilirubin Kontrolle
Diaglobal GmbH
·
,
DE
IVD General
CE/IVDD
MAS Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS® Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Ultimate-D Bilirubin Control Level 3
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Ultimate-D Bilirubin Control Level 4
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS® Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Ultimate-D Bilirubin Control Level 1
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)
Randox Laboratories Limited
·
,
XI
Class B
CE/IVDR
Ultimate-D Bilirubin Control Level 2
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS® Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
careSTART™ Total Bilirubin Biosensor Control
Wells Bio, Inc.
·
,
KR
IVD General
CE/IVDD
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS® Bilirubin Liquid Assayed Bilirubin Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
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