Procleix Xpress® System

Basic Information

• Brand Name: Procleix Xpress® System
• Primary DI: 00866489000029
• Version / Model: Version 2.0
• Catalog Number: 740807
• Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.
• Labeler DUNS: 056570085
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-09
• Public Version: 1
• Public Version Date: 2019-05-17
• Public Version Status: New
• Public Device Record Key: 7f8a7fc3-1a26-46fe-808c-0cb66cc7af4e

Device Description

The Procleix Xpress® System v2.0 (Software and instrument) is intended to be used to create whole blood lysates and pools of whole blood lysates 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
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	00866489000029	GS1

Customer Contacts

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