Procleix Xpress® System 741632

GUDID 00859882007764

The Procleix Xpress System v2.1 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate 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.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD Pipetting system IVD
Primary Device ID00859882007764
NIH Device Record Keyefca65b5-e25c-4252-ae40-a8a89185271a
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix Xpress® System
Version Model NumberVersion 2.1
Catalog Number741632
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com
Phone1-888-244-7667
EmailDxSCMCustomer.Service@grifols.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859882007764 [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 Date2021-07-09
Device Publish Date2021-07-01

On-Brand Devices [Procleix Xpress® System ]

00866489000012The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is
00866489000005The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is
00866489000029The Procleix Xpress® System v2.0 (Software and instrument) is intended to be used to create who
00859882007764The Procleix Xpress System v2.1 (Software and Instrument) is intended to be used to create whole
00866489000098The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole

Trademark Results [Procleix Xpress]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROCLEIX XPRESS
PROCLEIX XPRESS
85332508 4128122 Live/Registered
GRIFOLS WORLDWIDE OPERATIONS LIMITED
2011-05-27
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