Procleix Xpress® System 718463

GUDID 00866489000012

The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of  human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates 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.

Electronic pipette, multifunction

• Primary Device ID: 00866489000012
• NIH Device Record Key: 6d557b9e-1a57-4c8e-b976-dc8847d60c58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Xpress® System
• Version Model Number: 718463
• Catalog Number: 718463
• Company DUNS: 056570085
• Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1-800-452-6877
• Email: service.americas@grifols.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866489000012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140150

FDA Product Code

• MMH: Software, Blood Bank, Stand Alone Products

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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