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510(k) Data Aggregation
K Number
K020823Device Name
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
Manufacturer
SANQUIN BLOOD SUPPLY FOUNDATION
Date Cleared
2002-05-14
(61 days)
Product Code
DFZ
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
SANQUIN BLOOD SUPPLY FOUNDATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The contents of the Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE® Immunochemistry System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.
Device Description
Sheep antibodies to human IgG subclasses with the four subclasses of human IgG immunoglobulins, forming immuno-precipitates. This reaction consequently causes changes in the intensity of scattered light at a rate that increases gradually at first, then rapidly and finally proceeds through a peak rate of change (peak rate value) for the component being analyzed.
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