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Found 4 results
510(k) Data Aggregation
K Number
K161508Device Name
Ceruloplasmin
Manufacturer
BECKMAN COULTER IRELAND INC.
Date Cleared
2017-01-09
(222 days)
Product Code
DDB
Regulation Number
866.5210Why did this record match?
Product Code :
DDB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.
Device Description
The Ceruloplasmin reagent kit is in a liquid, ready to use form. It is available in one format OSR6164 which consists of 4 x 18mL R1 vials and 4 x 5ml R2 vials. The calibrator is a Beckman Coulter Serum protein multi-calibrator ODR3023 which is sold separately. Ceruloplasmin is a turbidimetric method the basis for this method is the measurement of the decrease in light transmitted (increase in absorbance) through the particles suspended in solution as a result of complexes formed during the antigen-antibody reaction. The Ceruloplasmin reagent is designed for optimal performance on the Beckman Coulter AU analyzers.
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K Number
K122965Device Name
HUMAN CAERULOPLASMIN KIT
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-06-03
(252 days)
Product Code
DDB
Regulation Number
866.5210Why did this record match?
Product Code :
DDB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Human Ceruloplasmin Kit for use on SPAPlus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
Not Found
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K Number
K053074Device Name
N ANTISERA TO HUMAN CERULOPLASMIN
Manufacturer
DADE BEHRING, INC.
Date Cleared
2006-03-16
(135 days)
Product Code
DDB
Regulation Number
866.5210Why did this record match?
Product Code :
DDB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinization of only and one of immunonephelometry on the BN™ Systems.
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of ceruloplasmin aids in the diagnosis of cooply of metabolism disorders.
Device Description
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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K Number
K964762Device Name
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
Manufacturer
BECKMAN INSTRUMENTS, INC.
Date Cleared
1997-04-25
(149 days)
Product Code
DDB
Regulation Number
866.5210Why did this record match?
Product Code :
DDB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMMAGE Immunochemistry System Ceruloplasmin (CER) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human ceruloplasmin by rate nephelometry.
Device Description
The IMMAGE Immunochemistry System CER Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of ceruloplasmin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
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