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In vitro diagnostic medical devices
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Reagents
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Clinical chemistry
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Controls/standards/calibrators clinical chemistry
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Multicomponent controls (clinical chemistry)
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Assayed multicomponent controls (cc)
Assayed multicomponent controls (cc)
W0101050101
123 devices
Seronorm® Urine L-2
Sero As
·
,
Norway
IVD General
CE/IVDD
Aldolase And Glutathione Reductase Level 3 Control (Als & Glut Red Control 3)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
FDA 510(k)
K131776
Active
Cleared 18 Jul 2013
CE/IVDR
Clinical Chemistry Control LEV.1
Medicon Hellas SA
·
,
Greece
Class C
CE/IVDR
GUDID
on market
BioNorm (surowica kontrolna) 4x5 ml
BioMaxima Spółka Akcyjna
·
,
Poland
Class C
CE/IVDR
Autonorm® Clin Chem Liq L-1
Sero As
·
,
Norway
IVD General
CE/IVDD
Control Serum Level 2
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
ClinChem Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Cormay Serum Hp
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Precise Norm
Giesse Diagnostics SRL
·
,
Italy
IVD General
CE/IVDD
Autonorm® Clin Chem Liq L-3
Sero As
·
,
Norway
IVD General
CE/IVDD
Kit Antibiotici Controlli Interni Set B
CoQua Lab s.r.l
·
,
Italy
IVD General
CE/IVDD
Eurotrol epoc Calibration Verification Fluids
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
GUDID
on market
Contro-N, 20 x 5 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
Contro-P, 20 x 5 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
QC Solution
Genrui Biotech Inc.
·
,
China
IVD General
CE/IVDD
MAS UA Control Liquid Assayed Urinalysis Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Biochemistry Normal Control
Cypress Diagnostics
·
,
Belgium
IVD General
CE/IVDD
Precise Path
Giesse Diagnostics SRL
·
,
Italy
IVD General
CE/IVDD
KEYU Urine Analyzer Quality Control Set
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
China
IVD General
CE/IVDD
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