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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
Hct Control Level C
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
GUDID
on market
MAS Alcohol/Ammonia
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Vivadiag Plus
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Homocystein Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Lactat Kontroll Set
Diaglobal GmbH
·
,
Germany
IVD General
CE/IVDD
A1C Hd Control
ARKRAY Factory, Inc.
·
,
Japan
IVD General
CE/IVDD
BioNorm R
BioMaxima Spółka Akcyjna
·
,
Poland
Class C
CE/IVDR
Total Bile Acids (TBA) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Total Antioxidant Status (Tas Control)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Vitamin D Control – OnSight™ Vitamin D Quantitative Test
Affimedix, Inc.
·
,
United States
IVD General
CE/IVDD
GlucoTrol-NG Level 4
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
Control Kit - PHOS L1
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
OSAXYL Control Kit
Biolan Microbiosensores S.L.
·
,
Spain
IVD General
CE/IVDD
Osmocoll HNL Osmolality Controls
Elitechgroup Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Fungus (1-3)-β-D Glucan Control
Dynamiker Biotechnology (Tianjin) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Seronorm® Trace Elements Whole Blood L-1
Sero As
·
,
Norway
IVD General
CE/IVDD
Neutrophil Gelatinase-associated Lipocalin (NGAL) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
TPUC Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Seronorm® Trace Elements Urine L-1
Sero As
·
,
Norway
IVD General
CE/IVDD
MassTrak™ Steroid Serum QC Set 1
Waters Corporation
·
,
United States
Class B
CE/IVDR
GUDID
on market
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