Human genomic analysis interpretive software

Definition
An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) 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. This software is not an IVD device.
GUDID devices
11
Last updated
2025-03-31 12:45:51

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860013485405Targeted Genomics, LLCGENOMECONSULT, LLCGlutenID2025-03-21
00856826006210Applied BiosystemsAFFYMETRIX, INC.2.12024-10-30
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2023-10-16
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2023-07-19
0085946200639223andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2023-03-22
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2023-01-25
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2022-05-24
10190302017756Oncomine™ Dx Target Test User Guides and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONA516942022-01-23
10190302006071Oncomine™ Dx Target Test User Guides and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONA324612017-06-27
10190302015646Oncomine™ Dx Target Test User Guide and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONA496782021-01-14
B236SMG6300Sunquest Mitogen GeneticsSUNQUEST INFORMATION SYSTEMS, INC.6.32020-11-12