PERSONAL GENOME DIAGNOSTICS INC.

FDA Device Registration & Listing · Baltimore, MD, US · Registration 3011805506

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011805506
FEI Number
3011805506
Entity Name
PERSONAL GENOME DIAGNOSTICS INC.
City/State/Country
Baltimore, MD, US
Establishment Address
3600 Boston Street, Baltimore, MD 21224, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Personal Genome Diagnostics (Owner Number: 10059661)
Owner / Operator Contact Address
3600 Boston Street, Baltimore, MD 21224, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN230046
PMA Number
N/A

All Registered Proprietary Names

PGDx elio tissue complete PGDx elio plasma focus Dx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QFK Tumor Gene Profiling Test Unknown Class N N/A 2019-03-11
PZM Next Generation Sequencing Based Tumor Profiling Test Pathology Class 2 866.6080 2020-04-25
QFI Synthetic Next-Generation Sequencing Quality Control And Filler Material Unknown Class N N/A 2019-02-26
SBY High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids Pathology Class 2 866.6085 2024-08-23

Official Correspondent

Jennifer Dickey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Personal Genome Diagnostics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011805506. Last updated year: 2026. Please use registration number 3011805506 when referencing this establishment in official correspondence.
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