PGDx elio™ platform B0110900

GUDID 00192721000763

PERSONAL GENOME DIAGNOSTICS INC.

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

• Primary Device ID: 00192721000763
• NIH Device Record Key: be2d8122-a070-4ea6-a60a-00ec72cfb394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PGDx elio™ platform
• Version Model Number: B0110900
• Catalog Number: B0110900
• 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: true
• Serial Number: false
• 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	00192721000763 [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

Devices Manufactured by PERSONAL GENOME DIAGNOSTICS INC.

• 00192721001449 - PGDx elio™ server: 2021-08-09 PGDx elio™ server (128C)
• 00192721001456 - PGDx elio™ server: 2021-08-09 PGDx elio™ server (reconditioned 128C)
• 00192721001432 - PGDx elio™ server: 2020-07-16 PGDx elio™ server (reconditioned)
• 00192721000756 - PGDx elio™ server: 2020-05-19
• 00192721000763 - PGDx elio™ platform: 2020-05-19
• 00192721000763 - PGDx elio™ platform: 2020-05-19
• 00192721000770 - PGDx elio™ tissue complete: 2020-05-19 PGDx elio™ tissue complete software
• 00192721001241 - PGDx elio™ diversiPhi: 2020-05-19
• 00192721001418 - PGDx elio™ tissue complete: 2020-05-19 PGDx elio™ tissue complete reagent kit