GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software GS6101

GUDID 00860013470982

Geneseeq Technology Inc

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00860013470982
• NIH Device Record Key: 0532738f-ffec-426e-8347-e1d811e62af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software
• Version Model Number: GS6101
• Catalog Number: GS6101
• Company DUNS: 202829982
• Company Name: Geneseeq Technology Inc
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013470982 [Primary]

FDA Product Code

• PZM: Next Generation Sequencing Based Tumor Profiling Test

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: 2026-01-06
• Device Publish Date: 2025-12-29

Devices Manufactured by Geneseeq Technology Inc

• 00860013470982 - GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software: 2026-01-06
• 00860013470982 - GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software: 2026-01-06
• 00860013470999 - GENESEEQPRIME NGS Tumor Profiling Assay (FFPE): 2026-01-06