Procleix Xpress® System

Basic Information

• Brand Name: Procleix Xpress® System
• Primary DI: 00859882007764
• Version / Model: Version 2.1
• Catalog Number: 741632
• Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.
• Labeler DUNS: 056570085
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-01
• Public Version: 1
• Public Version Date: 2021-07-09
• Public Version Status: New
• Public Device Record Key: efca65b5-e25c-4252-ae40-a8a89185271a

Device Description

The Procleix Xpress System v2.1 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QBZ	Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma	Clinical Chemistry	862.2750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65174	Pipetting system IVD	An electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859882007764	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]