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Procleix Xpress System

FDA UDIEUDAMED

Class I (US FDA UDI)

by Grifols Diagnostic Solutions Inc.

Identity

Trade Name
Procleix Xpress System FDA UDI
Generic Name
Nucleic acid sample preparation instrument IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
Version 4.0 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
742248 FDA UDI
Primary DI / UDI-DI
00859882007948 FDA UDI
FDA Product Code
QBZ FDA UDI
GMDN Term
Nucleic acid sample preparation instrument IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nucleic acid sample preparation instrument IVD

Procleix Xpress System by Grifols Diagnostic Solutions Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid sample preparation instrument IVD.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Grifols Diagnostic Solutions Inc.

Sources (2)

  • FDA UDI 74b3176c-4dbc-4827-92c7-5d01667224d5 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026