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OncoMate® MSI Dx Assay Installer

Software for installing OncoMate® MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer

Details

Device typeMicrosatellite instability IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC).

FDA categoryNucleic Acid Based Assay, Microsatellite Instability

Device ID00849811089114

Catalog numberMD4130

MRI safetyLabeling does not contain MRI Safety Information

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