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510(k) Data Aggregation
K Number
K964687Device Name
N LATEX CRP MONO REAGENT
Manufacturer
Date Cleared
1996-12-16
(90 days)
Product Code
Regulation Number
866.5270Why did this record match?
Product Code :
DCH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma.
Device Description
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma. In the proposed product polystyrene particles coated with mouse monoclonal antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.
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