PGDx elio™ server B-01-10800

GUDID 00192721000756

PERSONAL GENOME DIAGNOSTICS INC.

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00192721000756
• NIH Device Record Key: 8d300b03-25c1-4a46-96b6-2b84da8430e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PGDx elio™ server
• Version Model Number: B-01-10800
• Catalog Number: B-01-10800
• Company DUNS: 963427120
• Company Name: PERSONAL GENOME DIAGNOSTICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192721000756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192063

FDA Product Code

• PZM: Next Generation Sequencing Based Tumor Profiling Test

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-19
• Device Publish Date: 2020-05-11

On-Brand Devices [PGDx elio™ server]

• 00192721000756: B-01-10800
• 00192721001432: PGDx elio™ server (reconditioned)
• 00192721001456: PGDx elio™ server (reconditioned 128C)
• 00192721001449: PGDx elio™ server (128C)