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Sign in to claim this brandPersonal Genome Diagnostics, Inc.
United States·US-MF-000026862
Last updated September 18, 2026
About
Labcorp Oncology provides cancer testing services and genetic testing for cancer predisposition.
From the manufacturer's own website. Source
What Personal Genome Diagnostics, Inc. makes
The company develops in vitro diagnostic (IVD) kits and systems for detecting multiple gene mutations and mRNA expression related to cancer. These include platforms for analyzing tissue and plasma samples, such as the elio™ platform and its associated tissue and plasma-focused assays, as well as tools for genomic profiling like diversiPhi.
The portfolio includes devices classified as Class A, Class C, and Class II, with listings in the EUDAMED registry, FDA’s 510(k) and UDI systems. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Personal Genome Diagnostics, Inc. manufacture?
Personal Genome Diagnostics, Inc. specializes in in vitro diagnostic (IVD) devices focused on cancer-related testing. Their products primarily include kits and systems designed to detect multiple gene mutations and mRNA expression, such as the elio™ platform for tissue and plasma analysis. These tools enable genomic profiling and molecular diagnostics, helping identify biomarkers associated with cancer.
Where is Personal Genome Diagnostics, Inc. based?
The company is headquartered in the United States. Its operations and regulatory listings reflect a focus on serving global markets, particularly in regions where its devices are authorized, such as the EU and the US.
Which regulatory registries list Personal Genome Diagnostics, Inc.’s devices?
Personal Genome Diagnostics, Inc.’s devices are listed in key regulatory databases, including EUDAMED for European Union compliance, the FDA’s 510(k) premarket notification system, and the FDA’s Unique Device Identifier (UDI) database. These listings help track authorized devices and their classification under relevant regulatory frameworks.
How are Personal Genome Diagnostics, Inc.’s devices classified under regulatory standards?
The company’s devices fall into different regulatory classes depending on their risk level and intended use. For example, some are classified as Class A (low risk), while others are Class C or Class II (higher risk due to their role in cancer diagnostics). Classification determines the regulatory pathway and scrutiny required for authorization, ensuring safety and performance standards are met.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 3600 Boston St, Suite 10, Baltimore, United States
- Website
- www.personalgenome.com/
- linkedin.com/company/labcorp
- facebook.com/Labcorp
- [email protected]
- Phone
- —
- PRRC Contact
- Jennifer Dickey
- EUDAMED SRN
- US-MF-000026862
- FDA FEI Number
- —
- DUNS Number
- 963427120
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PGDx elio™ platform | B0110900 | FDA UDI | Class II | Active |
| PGDx elio™ server | B-01-30800 | FDA UDI | Class II | Active |
| PGDx elio™ tissue complete | B01103200 | FDA UDI | Class II | Active |
| PGDx elio™ server | B-01-40800 | FDA UDI | Class II | Active |
| PGDx elio™ server | B-01-10800 | FDA UDI | Class II | Active |
| PGDx elio™ server | B-01-20800 | FDA UDI | Class II | Active |
| PGDx elio™ tissue complete | A0320100 | FDA UDI | Class II | Active |
| PGDx elio plasma focus Dx | DEN230046 | FDA 510(k) | Class II | Active |
| PGDx elio diversiPhi | A0840101 | EUDAMEDFDA UDI | Class A | Active |
| PGDx elio tissue complete | A0220100 | EUDAMED | Class C | Active |
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