PGDx elio™ platform

Basic Information

• Brand Name: PGDx elio™ platform
• Primary DI: 00192721000763
• Version / Model: B0110900
• Catalog Number: B0110900
• Company Name: PERSONAL GENOME DIAGNOSTICS INC.
• Labeler DUNS: 963427120
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-11
• Public Version: 2
• Public Version Date: 2021-08-09
• Public Version Status: Update
• Public Device Record Key: be2d8122-a070-4ea6-a60a-00ec72cfb394

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZM	Next Generation Sequencing Based Tumor Profiling Test	Pathology	866.6080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60943	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192721000763	GS1

Premarket Submissions

Submission Number	Supplement Number
K192063	000