Pathology
xT CDx
Tempus Labs, Inc.
FDA-cleared AI medical device
A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
FDA Submission Metadata
- Submission number
- P210011
- Decision date
- April 2023
- FDA panel
- Pathology
- Product code
- PQP
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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