PGDx elio™ server B-01-20800

GUDID 00192721001432

PGDx elio™ server (reconditioned)

PERSONAL GENOME DIAGNOSTICS INC.

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• Primary Device ID: 00192721001432
• NIH Device Record Key: 0f719917-2977-464f-94b8-18b326694546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PGDx elio™ server
• Version Model Number: B-01-20800
• Catalog Number: B-01-20800
• 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: false
• 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	00192721001432 [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: 2020-07-16
• Device Publish Date: 2020-07-08

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)