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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
Apolipoprotein A-I (Apo A-I) Standard
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Calibrator for Automatic System (Multi-Cal)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Protein (Urine) Standard
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
ClinCal® Urine Calibrator, lyophil., for Trace Elements
RECIPE Chemicals + Instruments GmbH
·
,
Germany
IVD General
CE/IVDD
sCal
Thermo Fisher Scientific Oy
·
,
Finland
Class C
CE/IVDD
CE/IVDR
F&A2 Calibrator Set 2
Tosoh Corporation
·
,
Japan
IVD General
CE/IVDD
ReferrIL E
Instrumentation Laboratory SpA
·
,
Italy
Class C
CE/IVDR
INDIKO ISE Calibrator 1
Thermo Fisher Scientific Oy
·
,
Finland
Class B
CE/IVDR
NeoMass AAAC Plus Internal Standard - Labelled Argininosuccinic Acid (ISTD - AS…
Labsystems Diagnostics Oy
·
,
Finland
IVD General
CE/IVDD
Calibrator for Automatic System (Multi-Cal)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
NeoMass AAAC Plus Internal Standard - Labelled Succinylacetone (ISTD - SUAC)
Labsystems Diagnostics Oy
·
,
Finland
IVD General
CE/IVDD
Calibrant Fluid Pack
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Calibrant Fluid Pack
Edan Instruments, Inc.
·
,
China
IVD General
FDA 510(k)
K151978
Active
Cleared 15 Jul 2016
CE/IVDD
SYNCHRON Systems CAL 1 Calibrator 1
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Calibrant Fluid Pack
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
ISE Urine Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Calibrator for Automatic System (Multi-Cal)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
SP-Multical
Egyptian Company For Biotechnology-Spectrum Diagnostics
·
,
Egypt
IVD General
CE/IVDD
SYNCHRON Systems AQUA CAL 1
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Hb A1c CAPILLARY CALIBRATORS (5x2)
Sebia
·
,
France
Class C
CE/IVDR
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