FDA UDI
In Commercial Distribution
🇺🇸 United States
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software
DI: 00860013470982
·
Model: GS6101
·
Geneseeq Technology Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software
- Primary DI
- 00860013470982
- Version / Model
- GS6101
- Catalog Number
- GS6101
- Company Name
- Geneseeq Technology Inc
- Labeler DUNS
- 202829982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-29
- Public Version
- 1
- Public Version Date
- 2026-01-06
- Public Version Status
- New
- Public Device Record Key
- 0532738f-ffec-426e-8347-e1d811e62af8
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PZM | Next Generation Sequencing Based Tumor Profiling Test | Pathology | 866.6080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60943 | Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013470982 | GS1 |