Pathology
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
Geneseeq Technology Inc.
A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.
FDA Submission Metadata
- Submission number
- K250003
- Decision date
- August 2025
- FDA panel
- Pathology
- Product code
- PZM
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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