Procleix Xpress System 742248

GUDID 00859882007948

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 (MPT), 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 MPT composition. The Procleix Xpress System is intended to create whole blood lysates and/or 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 MPT. The pooled or individual lysates may be used for further testing in Procleix systems. 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

• Primary Device ID: 00859882007948
• NIH Device Record Key: 74b3176c-4dbc-4827-92c7-5d01667224d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix Xpress System
• Version Model Number: Version 4.0
• Catalog Number: 742248
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859882007948 [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: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC.

• 00859882007948 - Procleix Xpress System: 2023-06-19The 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 (MPT), 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 MPT composition. The Procleix Xpress System is intended to create whole blood lysates and/or 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 MPT. The pooled or individual lysates may be used for further testing in Procleix systems. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
• 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
• 00850032683005 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683012 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683029 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683036 - Procleix HIV-1/HCV/HBV Quality Control: 2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
• 00850032683043 - 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
• 00850032683050 - 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
• 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