Search Results
Found 1 results
510(k) Data Aggregation
K Number
K994110Device Name
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
Manufacturer
Date Cleared
1999-12-21
(15 days)
Product Code
Regulation Number
866.5600Why did this record match?
Applicant Name (Manufacturer) :
DIASORIN/AMERICAN STANDARD COMPANIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FOR IN VITRO DIAGNOSTIC USE. The SPQ TM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations.
Device Description
Lipoprotein(a) Immunological Test Kit
Ask a Question
Ask a specific question about this device
Page 1 of 1