← Product Code [PQP](/productcode/PQP) · P250036

# PGDx elio tissue complete CDx (P250036)

_Personal Genome Diagnostics, Inc. · PQP · Jul 30, 2026 · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P250036

## Device Facts

- **Applicant:** Personal Genome Diagnostics, Inc.
- **Product Code:** [PQP](/productcode/PQP.md)
- **Decision Date:** Jul 30, 2026
- **Decision:** APPR
- **Device Class:** Class 3

## Regulatory Identification

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.

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**Source:** [https://fda.innolitics.com/device/P250036](https://fda.innolitics.com/device/P250036)

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