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 ID00866489000036
NIH Device Record Keyf7bc052b-268c-40e3-8570-5328dfe25275
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix Xpress System Software
Version Model NumberVersion 3.0
Catalog Number740769
Company DUNS056570085
Company NameGRIFOLS DIAGNOSTIC SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-452-6877
Emailservice.americas@grifols.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866489000036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMHBlood Establishment Computer Software And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-31

Devices Manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC.

00850032683517 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
00850032683524 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
00850032683531 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
00850032683548 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
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
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