Identity
- Trade Name
- Targeted Genomics, LLC FDA UDI
- Generic Name
- Human genomic analysis interpretive software FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- GlutenID FDA UDI
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013485405 FDA UDI
- FDA Product Code
- PTA FDA UDI
- GMDN Term
- Human genomic analysis interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Human genomic analysis interpretive software
Targeted Genomics, LLC by Genomeconsult, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genomeconsult, Llc
Sources (1)
- FDA UDI a1670059-2c24-4478-a89d-7ee3edc82fff 34 fields · synced May 30, 2026