Personal Genome Diagnostics Inc. (manufacturer, Baltimore, MD): 1 new FDA device listing, incl. next generation sequencing oncology panel, somatic or germline variant
Personal Genome Diagnostics Inc. (Baltimore, Maryland): 1 new FDA device listing, incl. next generation sequencing oncology panel, somatic or germline variant. Its amount of 1 is above the median of 2 (50th percentile). Dated 18 days ago, it is in the active follow-up window. Score 80/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 14 related MD DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Personal Genome Diagnostics Inc. |
| Owner / operator | Personal Genome Diagnostics |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Baltimore, MD, US |
| New listings | 1 |
| Devices | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Product codes | PQP |
| Device classes | Class III |
| Brand names | PGDx elio tissue complete CDx |
| First new listing | 2026-10-19 |
| Latest new listing | 2026-10-19 |
| FDA registration number | 3011805506 |
| Registration expires | 2027-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (15 MD records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-19
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Personal Genome Diagnostics Inc. and 15 Maryland peers
- Maryland DeviceEstablishmentPulse records like this one: 15
- Personal Genome Diagnostics Inc.'s amount: 50th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Maryland peer: $3,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Personal Genome Diagnostics Inc. in Baltimore, Maryland?
Personal Genome Diagnostics Inc. (Baltimore, MD), a manufacturer, added 1 FDA device listing on 2026-10-19.
How does Personal Genome Diagnostics Inc. compare to other Maryland DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 18 days old, still within a typical 45-day follow-up window. Its Score of 80/100 puts it among the stronger signals in this feed.
Personal Genome Diagnostics Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Personal Genome Diagnostics Inc. | Baltimore, MD | 1 | 50th | 2026-10-19 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Tornier, Inc. | Bloomington, MN | 3 | 77th | 2026-10-21 |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL | 3 | 77th | 2026-10-20 |
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Maryland
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.