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 Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD
Primary Device ID00859882007948
NIH Device Record Key74b3176c-4dbc-4827-92c7-5d01667224d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix Xpress System
Version Model NumberVersion 4.0
Catalog Number742248
Company DUNS056570085
Company NameGRIFOLS DIAGNOSTIC SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859882007948 [Primary]

FDA Product Code

QBZAutomated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

Devices Manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC.

00859882007948 - Procleix Xpress System2023-06-19The 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 System2023-06-19 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 Control2023-02-23 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 Control2023-02-23 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 Control2023-02-23 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 Control2023-02-23 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 Control2023-02-23 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 Control2023-02-23 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 Control2023-02-23 Procleix Babesia/WNV Quality Control, a set of quality controls, is intended for use as an external assayed quality control mate
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