Procleix Xpress® System 741743

GUDID 00866489000098

The Procleix Xpress System v3.2 (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. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Nucleic acid sample preparation instrument IVD, semi-automated

• Primary Device ID: 00866489000098
• NIH Device Record Key: 1dc82f62-2f11-4fdb-ba79-70b113c9fedd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Xpress® System
• Version Model Number: Version 3.2
• Catalog Number: 741743
• Company DUNS: 056570085
• Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866489000098 [Primary]

FDA Product Code

• QBZ: Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

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: 2022-02-24
• Device Publish Date: 2022-02-16

On-Brand Devices [Procleix Xpress® System]

• 00866489000012: The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is
• 00866489000005: The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is
• 00866489000029: The Procleix Xpress® System v2.0 (Software and instrument) is intended to be used to create who
• 00859882007764: The Procleix Xpress System v2.1 (Software and Instrument) is intended to be used to create whole
• 00866489000098: The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole