Procleix Xpress System Software 740769

GUDID 00866489000036

The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of  human plasma or serum for 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.

Pipetting system

• Primary Device ID: 00866489000036
• NIH Device Record Key: f7bc052b-268c-40e3-8570-5328dfe25275
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Xpress System Software
• Version Model Number: Version 3.0
• Catalog Number: 740769
• 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: false
• Manufacturing Date: false
• 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	00866489000036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170162

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-31

Devices Manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC.

• 00859882007948 - Procleix Xpress System: 2023-06-19 The Procleix Xpress System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood s
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• 00850032683067 - Procleix Babesia/WNV Quality Control: 2023-02-23 Procleix Babesia/WNV Quality Control, a set of quality controls, is intended for use as an external assayed quality control mate