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In vitro diagnostic medical devices
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Controls/standards/calibrators clinical chemistry
Controls/standards/calibrators clinical chemistry
W010105
1,193 devices
Subcategories
3
W01010501
Multicomponent controls (clinical chemistry)
232
devices
›
W01010502
Specific controls (clinical chemistry)
498
devices
›
W01010503
Calibrators and standards (clinical chemistry)
463
devices
›
Devices
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
ClinCal® Serum Calibrator, lyophil., for Vitamins B6
RECIPE Chemicals + Instruments GmbH
·
,
Germany
Class B
CE/IVDR
Apolipoprotein A1 Reagent Kit(immunoturbidimetric Method)
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Kit Antibiotici Curva Di Calibrazione Set B
CoQua Lab s.r.l
·
,
Italy
IVD General
CE/IVDD
Kalibrator CK-MB
BioMaxima Spółka Akcyjna
·
,
Poland
Class C
CE/IVDR
Direct Ldl/Hdl Cholesterol Calibrator
Open recall
Randox Laboratories Limited
·
,
Northern Ireland
Class B
FDA 510(k)
×4
K153435
Active
Cleared 8 Jan 2016
CE/IVDR
+1
authorizations
ISE blood sample calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
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