PGDx elio™ diversiPhi A0840101

GUDID 00192721001241

PERSONAL GENOME DIAGNOSTICS INC.

Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00192721001241
• NIH Device Record Key: 451b1812-a96e-4c5c-9bc2-9b02a56cbc9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PGDx elio™ diversiPhi
• Version Model Number: A0840101
• Catalog Number: A0840101
• Company DUNS: 963427120
• Company Name: PERSONAL GENOME DIAGNOSTICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00192721001241 [Primary]

FDA Product Code

• PFT: Reagents For Molecular Diagnostic Test Systems

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
• 00192721000770 - PGDx elio™ tissue complete: 2020-05-19 PGDx elio™ tissue complete software
• 00192721001241 - PGDx elio™ diversiPhi: 2020-05-19
• 00192721001241 - PGDx elio™ diversiPhi: 2020-05-19
• 00192721001418 - PGDx elio™ tissue complete: 2020-05-19 PGDx elio™ tissue complete reagent kit