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In vitro diagnostic medical devices
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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
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
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
GUDID
on market
Blood Gas Analyzer Control
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
lood Gas Analyzer Control
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
GUDID
on market
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
GUDID
on market
Ammonia Control
Medicon Hellas SA
·
,
Greece
IVD General
CE/IVDD
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