PGDx elio tissue complete CDx
Device Facts
| Record ID | P250036 |
|---|---|
| Device Name | PGDx elio tissue complete CDx |
| Applicant | Personal Genome Diagnostics, Inc. |
| Product Code | PQP |
| Decision Date | Jul 30, 2026 |
| Decision | APPR |
| Device Class | Class 3 |
Regulatory Classification
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.
