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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
One‐trol 2
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
GlucoTrol-NG Level 3
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
GlucoTrol-NG Level 1
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
invitrol® Elpho abnormal
invicon diagnostic concepts GmbH
·
,
Germany
IVD General
CE/IVDD
α‐1 Microglobulin Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
sLDL CONTROL LEVEL 2 (sLDL CONTROL 2)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Specific Protein Control Serum
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Uric Acid Control Solutions
Eaglenos Sciences, Inc.
·
,
China
IVD General
CE/IVDD
FUN Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Seronorm® Trace Elements Whole Blood L-3
Sero As
·
,
Norway
IVD General
CE/IVDD
Aptiva® Optical Control Kit
Inova Diagnostics, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
GlucoTrol Level 1
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
ClinChek® Serum Control, lyophil., for CDT, Level I, II
RECIPE Chemicals + Instruments GmbH
·
,
Germany
Class B
CE/IVDR
β2-MG Clinchem Control
Autobio Biochemistry Co., Ltd
·
,
China
Class B
CE/IVDR
Creatine Kinase MB Isoenzymes (CK-MB) quality control products
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
Neutrophil Gelatinase-associated Lipocalin (NGAL) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HDL/LDL Cholesterol Control Serum
Beckman Coulter Ireland Inc.
·
,
Ireland
Class B
CE/IVDR
Cormay Bile Acids Controls
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Neutrophil Gelatinase-associated Lipocalin (NGAL) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MassTrak™ Steroid Serum QC Set 3
Waters Corporation
·
,
United States
Class B
CE/IVDR
GUDID
on market
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