Procleix Xpress® System

Primary DI
00866489000098
Brand
Procleix Xpress® System
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
Version 3.2
Catalog number
741743
Device description
The Procleix Xpress System v3.2 (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. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
Published
2022-02-16
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
00866489000098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866489000098008664890000988664890000980866489000098

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the pre-analytical preparation of samples for downstream nucleic acid amplification/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, nucleic acid purification, and/or nucleic acid thermal incubation. The device operates with minimal technician involvement and automation of some but not all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056570085
Device count
1
Premarket exempt
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
00859882007948Procleix Xpress SystemGRIFOLS DIAGNOSTIC SOLUTIONS INC.QBZ2023-06-09
00859882007764Procleix Xpress® System GRIFOLS DIAGNOSTIC SOLUTIONS INC.QBZ2021-07-01
00866489000029Procleix Xpress® System GRIFOLS DIAGNOSTIC SOLUTIONS INC.QBZ2019-05-09