PGDx elio™ diversiPhi A0840101

GUDID 00192721001241

PERSONAL GENOME DIAGNOSTICS INC.

Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay 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