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In vitro diagnostic medical devices
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Clinical chemistry
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Controls/standards/calibrators clinical chemistry
Controls/standards/calibrators clinical chemistry
W010105
1,193 devices
Subcategories
3
W01010501
Multicomponent controls (clinical chemistry)
232
devices
›
W01010502
Specific controls (clinical chemistry)
498
devices
›
W01010503
Calibrators and standards (clinical chemistry)
463
devices
›
Devices
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
VALIDATE® GC4 Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
careSTART™ Total Bilirubin Biosensor Control
Wells Bio, Inc.
·
,
South Korea
IVD General
CE/IVDD
VALIDATE® GC4 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
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
VALIDATE® GC4 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
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Trilevel Quality Controls (For Z-Elite Pro+)
ZOVEC diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
Electrolyte Multiple Quality Control
Shenzhen Xilaiheng Medical Electronics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Sweat Controls, L1, L2, L3
Elitechgroup Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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