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Microsatellite instability IVD, kit, nucleic acid technique (NAT)

Definition
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).
GUDID devices
7
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
15415219001328Idylla CDx MSI TestBiocartis NVv32025-11-01
00849811083457OncoMate® MSI Dx Analysis SoftwarePROMEGA CORPORATIONMD41602026-02-16
00849811089114OncoMate® MSI Dx Assay InstallerPROMEGA CORPORATIONMD41302026-02-16
15415219000758Idylla™ MSI TestBiocartis NV22023-05-03
00849811056857OncoMate MSI Dx Interpretive SoftwarePROMEGA CORPORATIONMD41402021-10-08
00849811056864OncoMate MSI Dx Assay InstallerPROMEGA CORPORATIONMD41502021-10-08
00849811031717OncoMate MSI Dx Analysis SystemPROMEGA CORPORATIONMD21402021-09-30