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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
MAS UA Control Liquid Assayed Urinalysis Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MAS Urinalysis Liquid Urinalysis Control 3
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Elitrol I
Vitalscientific
·
,
France
Class B
CE/IVDR
GUDID
on market
Clinical Chemistry Control LEV.2
Medicon Hellas SA
·
,
Greece
Class C
CE/IVDR
GUDID
on market
AMMONIA ETHANOL CONTROL - LEVEL 2 (NH3/EtOH CONTROL 2)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
SeraChem Control Level 2
Instrumentation Laboratory SpA
·
,
Italy
Class C
CE/IVDR
Ammonia/Ethanol/CO2 Control I/Ii
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Seronorm® Immunoprotein Lyo L-1
Sero As
·
,
Norway
IVD General
CE/IVDD
invitrol® Urin dipStick Kombi
invicon diagnostic concepts GmbH
·
,
Germany
IVD General
CE/IVDD
Blood Gas, Electrolyte, Metabolite Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
Autonorm® Clin Chem Liq L-2
Sero As
·
,
Norway
IVD General
CE/IVDD
Cormay Urine Control Level 2
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
MAS Urinalysis Liquid Urinalysis Control 1
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Serum protein control normal
Seleo S.r.l.
·
,
Italy
IVD General
CE/IVDD
Controllo N
Futurlab S.R.L.
·
,
Italy
IVD General
CE/IVDD
Cormay Ammonia / Ethanol Controls
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Kit Antibiotici Controlli Interni Set A
CoQua Lab s.r.l
·
,
Italy
IVD General
CE/IVDD
Seronorm® Human High
Sero As
·
,
Norway
IVD General
CE/IVDD
invitrol® Urin dipStick L-1
invicon diagnostic concepts GmbH
·
,
Germany
IVD General
CE/IVDD
SeraChem Control Level 1
Instrumentation Laboratory SpA
·
,
Italy
Class C
CE/IVDR
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