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 in the assessment of adverse health condition risk, disease prevention, and/or health management. It can also be used by the patient for lifestyle guidance as pertains to their genomic profile.
GUDID devices
16
Last updated
2021-05-28 08:26:31

Related Product Codes

CodeDeviceSpecialtyClassDevices
PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality DetectionImmunology211
PTAGenetic Variant Detection And Health Risk Assessment SystemImmunology24
PKBAutosomal Recessive Carrier Screening Gene Mutation Detection SystemImmunology21
QAZCancer Predisposition Risk Assessment SystemMedical Genetics21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2021-05-19
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2020-03-09
00856826006104CytoScan Dx WS AAFFYMETRIX, INC.9020902016-09-23
0085946200611823andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2019-06-27
00856826006074AffymetrixAFFYMETRIX, INC.1.22016-09-23
00856826006081AffymetrixAFFYMETRIX, INC.5209692016-09-23
00856826006098AffymetrixAFFYMETRIX, INC.9021502016-09-23
00856826006111AffymetrixAFFYMETRIX, INC.9020912016-09-23
00856826006128AffymetrixAFFYMETRIX, INC.9021092016-09-23
00856826006135AffymterixAFFYMETRIX, INC.9021102016-09-23
00856826006142AffymetrixAFFYMETRIX, INC.9021072016-09-23
00856826006159AffymetrixAFFYMETRIX, INC.9021082016-09-23
00856826006166AffymetrixAFFYMETRIX, INC.9021112016-09-23
0085946200609523andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2018-07-17
0086215000006023andMe, Inc. Personal Genome Service®(PGS)23ANDME, INC.YouDot2017-04-17
00085626006104AffymetrixAFFYMETRIX, INC.9020902016-09-23