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: Pipetting system IVD FDA UDI
Device Name: 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. FDA UDI
Model / Reference: Version 2.1 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 741632 FDA UDI
Primary DI / UDI-DI: 00859882007764 FDA UDI
FDA Product Code: QBZ FDA UDI
GMDN Term: Pipetting system 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pipetting system IVD

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Grifols Diagnostic Solutions Inc.

Sources (1)

FDA UDI efca65b5-e25c-4252-ae40-a8a89185271a 35 fields · synced Jun 9, 2026