GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)

Basic Information

• Brand Name: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)
• Primary DI: 00860013470999
• Version / Model: GS6005
• Catalog Number: GS6005
• 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: 3177f2a6-edda-4c8e-8e01-a5a31b8acdbb

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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	00860013470999	GS1