FDA UDI
In Commercial Distribution
🇺🇸 United States
Targeted Genomics, LLC
DI: 00860013485405
·
Model: GlutenID
·
GENOMECONSULT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Targeted Genomics, LLC
- Primary DI
- 00860013485405
- Version / Model
- GlutenID
- Company Name
- GENOMECONSULT, LLC
- Labeler DUNS
- 003510723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-21
- Public Version
- 1
- Public Version Date
- 2025-03-31
- Public Version Status
- New
- Public Device Record Key
- a1670059-2c24-4478-a89d-7ee3edc82fff
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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PTA | Genetic Variant Detection And Health Risk Assessment System | Immunology | 866.5950 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61777 | Human genomic analysis interpretive software | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013485405 | GS1 |
Customer Contacts
- Phone
- 18009715938
- [email protected]