Procleix Xpress System Software

Basic Information

• Brand Name: Procleix Xpress System Software
• Primary DI: 00866489000036
• Version / Model: Version 3.0
• Catalog Number: 740769
• Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.
• Labeler DUNS: 056570085
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: f7bc052b-268c-40e3-8570-5328dfe25275

Device Description

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.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MMH	Blood Establishment Computer Software And Accessories	Hematology	864.9165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47832	Pipetting system	An assembly of devices designed to automatically pipette liquids in the laboratory for the preparation/concentration of analytes (e.g., cells, nucleic acids, microorganisms) in clinical specimens (e.g., blood, urine, sputum, faeces). It is software operated and automatically moves liquids by pipetting, and typically by mixing, heating, and magnetic particle handling. It typically includes a mains electricity (AC-powered) pipetting system, a heating module, shaker, barcode reader (for specimen traceability), adaptors, grippers, and sample racks. The system is commonly used with specialized kits for the extraction/isolation/concentration of analytes.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866489000036	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK170162	0