Procleix Xpress System

Primary DI
00859882007948
Brand
Procleix Xpress System
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
Version 4.0
Catalog number
742248
Device description
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.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBZAutomated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or PlasmaClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859882007948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859882007948008598820079488598820079480859882007948

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056570085
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859882007061Procleix Ultrio Plus Assay1K Kit Box 12018-02-06
00859882007078Procleix Ultrio Plus Assay1K Kit Box 22018-02-06
00859882007085Procleix Ultrio Plus Assay1K Kit Box 32018-02-06
00859882007092Procleix Ultrio Plus Assay1K Kit Box 42018-02-06
00859882007108Procleix Ultrio Plus Assay5K Kit Box 12018-02-06
00859882007115Procleix Ultrio Plus Assay5K Kit Box 22018-02-06
00859882007122Procleix Ultrio Plus Assay5K Kit Box 32018-02-06
00859882007139Procleix Ultrio Plus Assay5K Kit Box 42018-02-06
00859882007146Procleix Ultrio Plus Assay5K Kit Box 52018-02-06
00859882007153Procleix Ultrio Plus AssayHIV-1 dprobe kit2018-02-06
00859882007160Procleix Ultrio Plus AssayHCV dprobe kit2018-02-06
00859882007177Procleix Ultrio Plus AssayHBV dprobe kit2018-02-06
00859882007184Procleix Ultrio Plus AssayControls Kit2018-02-06
00859882007191Procleix Ultrio Plus AssayCalibrators Kit2018-02-06
00859882007207Procleix Ultrio Plus AssayNegative Calibrator Kit2018-02-06
00859882007214Procleix Ultrio Plus AssayNegative Control Kit2018-02-06
00859882007221Procleix Ultrio Assay1K Kit Box 12018-08-03
00859882007238Procleix Ultrio Assay1K Kit Box 22018-08-03
00859882007245Procleix Ultrio Assay1K Kit Box 32018-08-03
00859882007252Procleix Ultrio Assay5K Kit Box 12018-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866489000098Procleix Xpress® SystemGRIFOLS DIAGNOSTIC SOLUTIONS INC.QBZ2022-02-16
00859882007764Procleix Xpress® System GRIFOLS DIAGNOSTIC SOLUTIONS INC.QBZ2021-07-01
00866489000029Procleix Xpress® System GRIFOLS DIAGNOSTIC SOLUTIONS INC.QBZ2019-05-09