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510(k) Data Aggregation
K Number
K062746Device Name
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
Manufacturer
MEDICON HELLAS S.A.
Date Cleared
2006-11-20
(67 days)
Product Code
DBF
Regulation Number
866.5340Why did this record match?
Applicant Name (Manufacturer) :
MEDICON HELLAS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medicon Ferritin - LATEX reagent is for the determination of Ferritin in human serum and plasma using automated clinical chemistry analyzers.
The measurement of ferritin may aid in the diagnosis of diseases affecting iron metabolism.
For in vitro diagnostic use.
Device Description
The Ferritin – LATEX is an immunoturbidimetric assay. When serum or plasma specimen is mixed with the appropriate buffer (R1) and latex particles coated with anti-ferritin antibodies (R2), ferritin reacts with the antibodies leading to agglutination of latex particles. This agglutination is detected as turbidity change (600 nm) and it is proportional to ferritin concentration in the sample.
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