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510(k) Data Aggregation
K Number
K013278Device Name
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
Manufacturer
Date Cleared
2001-11-15
(45 days)
Regulation Number
866.5590Why did this record match?
Product Code :
DEL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma.
For the quantitative determination of apolipoprotein A-1 in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Device Description
Human apolipoprotein A-1 forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
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