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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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Multicomponent controls (clinical chemistry)
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Assayed multicomponent controls (cc)
Assayed multicomponent controls (cc)
W0101050101
123 devices
Devices
Control Serum Level 1
Beckman Coulter Ireland Inc.
·
,
IE
Class C
CE/IVDR
Seronorm® Urine L-1
Sero As
·
,
NO
IVD General
CE/IVDD
Control Serum Level 2
Shanghai Kehua Bio-engineering Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Spotchem Calibration Check
ARKRAY Factory, Inc.
·
,
JP
IVD General
CE/IVDD
Seronorm® Immunoprotein Liq L-1
Sero As
·
,
NO
IVD General
CE/IVDD
Precise Path
Giesse Diagnostics SRL
·
,
IT
IVD General
CE/IVDD
isatuximab CONTROL
Sebia
·
,
FR
Class A
CE/IVDR
GUDID
on market
Multi Control
Medicalsystem Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
SP-Normotrol
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
EG
IVD General
CE/IVDD
MAS® UrichemTRAK Liquid Assayed Urine Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
BioPath (surowica kontrolna) 4x5 ml
BioMaxima Spółka Akcyjna
·
,
PL
Class B
CE/IVDR
Biochemistry Pathological Control Specific
Cypress Diagnostics
·
,
BE
IVD General
CE/IVDD
Blood Gas, Electrolyte, Metabolite Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Controllo P
Futurlab S.R.L.
·
,
IT
IVD General
CE/IVDD
MAS UA Control Liquid Assayed Urinalysis Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Eurotrol epoc GAS-ISE Metabolites Level 1
Eurotrol B.V.
·
,
NL
IVD General
FDA 510(k)
K121468
Active
Cleared 22 Jun 2012
CE/IVDD
+1
authorizations
Seronorm® Paediatric
Sero As
·
,
NO
IVD General
CE/IVDD
MAS® UA DipTube Liquid Assayed Urinalysis Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Quality Control Solution (QC Solution)
Genrui Biotech Inc.
·
,
CN
IVD General
CE/IVDD
Elitrol Ii
Vitalscientific
·
,
FR
Class B
CE/IVDR
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