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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
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
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
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