Targeted Genomics, LLC

Primary DI
00860013485405
Brand
Targeted Genomics, LLC
Company
GENOMECONSULT, LLC
Model
GlutenID
Device description
The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from saliva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR).
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTAGenetic Variant Detection And Health Risk Assessment System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTAGenetic Variant Detection And Health Risk Assessment SystemImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013485405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013485405008600134854058600134854050860013485405

GMDN Terms#

Term, Definition table
TermDefinition
Human genomic analysis interpretive softwareAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18009715938customersupport@targeted-genomics.com

Regulatory Flags#

DUNS number
003510723
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-10-16
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-07-19
08437013457095A1AT Genotyping TestPROGENIKA BIOPHARMA, SAPTA2023-07-14
08437013457101A1AT Genotyping TestPROGENIKA BIOPHARMA, SAPTA2023-07-14
0085946200639223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-03-22
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-01-25
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2022-05-24
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2021-05-19
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2020-03-09
0085946200611823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2019-06-27
0085946200609523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2018-07-17
0085946200602623andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2017-04-17
0086215000006023andMe, Inc. Personal Genome Service®23ANDME GENOMICS LLCPTA2016-09-21