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Procleix Xpress® System

FDA UDI

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, semi-automated FDA UDI
Device Name
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. FDA UDI
Model / Reference
Version 3.2 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
741743 FDA UDI
Primary DI / UDI-DI
00866489000098 FDA UDI
FDA Product Code
QBZ FDA UDI
GMDN Term
Nucleic acid sample preparation instrument IVD, semi-automated 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nucleic acid sample preparation instrument IVD, semi-automated

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

Similar devices

Also classified as Nucleic acid sample preparation instrument IVD, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Grifols Diagnostic Solutions Inc.

Sources (1)

  • FDA UDI 1dc82f62-2f11-4fdb-ba79-70b113c9fedd 34 fields · synced Jun 9, 2026