Targeted Genomics, LLC

GUDID 00860013485405

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).

GENOMECONSULT, LLC

Human genomic analysis interpretive software

• Primary Device ID: 00860013485405
• NIH Device Record Key: a1670059-2c24-4478-a89d-7ee3edc82fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Targeted Genomics, LLC
• Version Model Number: GlutenID
• Company DUNS: 003510723
• Company Name: GENOMECONSULT, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com
• Phone: 18009715938
• Email: customersupport@targeted-genomics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013485405 [Primary]

FDA Product Code

• PTA: Genetic Variant Detection And Health Risk Assessment System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-31
• Device Publish Date: 2025-03-21