Human genomic analysis interpretive software IVD

Definition
An in vitro diagnostic interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile.
GUDID devices
12
Last updated
2026-01-05 18:31:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00613745002910KMRengine Chimerism monitoring software One year extension GenBio41097512025-12-26
00613745003740NGSengine Analysis software for KIRGenBio41022402025-12-26
00613745003757NGSengine Analysis Software for Non-Classical + Non-HLA GenesGenBio41034402025-12-26
00613745003764NGSignitionGenBio41055402025-12-26
00613745003771TRKengine Standard Extension (1 year) GenBio41077722025-12-26
00613745003788NGSengine Premium Extension (5 years)GenBio41096402025-12-26
00613745003795NGSengine Standard Extension (1 year)GenBio41097402025-12-26
00613745003801NGSengine-Turbo Standard Extension (1 year)GenBio41097832025-12-26
00613745003818NGSengine Standard Entry (1 year)GenBio41099402025-12-26
00613745003825NGSengine-Turbo Standard Entry (1 year)GenBio41099832025-12-26
00613745003856SBTengine One Year ExtensionGenBio41097302025-12-26
06438147373901Eonis Analysis softwareWallac Oy5020-10002022-12-02