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Controls/standards/calibrators clinical chemistry
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Calibrators and standards (clinical chemistry)
Calibrators and standards (clinical chemistry)
W01010503
463 devices
Subcategories
4
W0101050301
Calibrators multicomponent (cc)
136
devices
W0101050302
Calibrators single component (cc)
109
devices
W0101050303
Aqueous standards (cc)
29
devices
W0101050399
Calibrators and standards (clinical chemistry) - other
189
devices
Devices
Ammonia/Ethanol/CO2 Calibrator
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
BioCal (4x3 ml)
BioMaxima Spółka Akcyjna
·
,
Poland
Class C
CE/IVDR
ClinCal® Urine Calibrator, lyophil., for Phenolic Compounds
RECIPE Chemicals + Instruments GmbH
·
,
Germany
IVD General
CE/IVDD
ClinCal® Urine Calibrator, lyophil., for Occupational Medicine
RECIPE Chemicals + Instruments GmbH
·
,
Germany
IVD General
CE/IVDD
Ise Calibrators
Vitalscientific
·
,
France
Class B
CE/IVDR
GUDID
on market
eCal
Thermo Fisher Scientific Oy
·
,
Finland
Class C
CE/IVDR
Calibrant Fluid Pack
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Bilirubin Calibrator
Fujifilm Wako Pure Chemical Corporation
·
,
Japan
Class B
CE/IVDR
ISE Calibrator 4
Thermo Fisher Scientific Oy
·
,
Finland
Class B
CE/IVDR
SYNCHRON® Systems SYNCHRON Multi Calibrator
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K110251
Active
Cleared 25 May 2011
CE/IVDD
+1
authorizations
Calibrant Fuild Pack
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
G8 Hemoglobin F&A2 Calibrator
Tosoh Corporation
·
,
Japan
IVD General
CE/IVDD
ReferrIL G
Instrumentation Laboratory SpA
·
,
Italy
Class C
CE/IVDR
Ise Calibrators
Vitalscientific
·
,
France
Class B
CE/IVDR
Multiple biochemical calibrators
URIT Medical Electronic Co., Ltd.
·
,
China
Class B
CE/IVDR
Multiple biochemical calibrators
URIT Medical Electronic Co., Ltd.
·
,
China
Class B
CE/IVDR
Multi Sera Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
NeoMass AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA)
Labsystems Diagnostics Oy
·
,
Finland
IVD Annex II List B
CE/IVDD
ISE Calibrator 1
Thermo Fisher Scientific Oy
·
,
Finland
Class B
CE/IVDR
ClinCal® Whole Blood Calibrator, lyophil., for Trace Elements
RECIPE Chemicals + Instruments GmbH
·
,
Germany
IVD General
CE/IVDD
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