Identity
- Trade Name
- Procleix Xpress System EUDAMEDProcleix Xpress® System FDA UDI
- Generic Name
- Electronic pipette FDA UDI
- Device Name
- Procleix Xpress System EUDAMEDThe Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as 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, 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 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
- 718431 EUDAMED30055067 FDA UDI
- Description
- The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as 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, 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 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
- 30055067 FDA UDI
- Primary DI / UDI-DI
- 00866489000005 EUDAMEDFDA UDI
- Basic UDI-DI
- 08664890000Xpress001YG EUDAMED
- Direct Marketing DI
- 00866489000005 EUDAMED
- FDA Product Code
- MMH FDA UDI
- EMDN Code
- W02060180 ROBOTIC SAMPLE PROCESSING SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electronic pipette FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9165 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Procleix Xpress System by Grifols Diagnostic Solutions Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08664890000Xpress001YG | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Grifols Diagnostic Solutions Inc.
- EUDAMED SRN
- US-MF-000004304
- Authorised Representative
- Diagnostic Grifols, S.A. ES-AR-000001573
Sources (2)
- EUDAMED ebec76b6-e4f3-4357-b787-52672890a21c 61 fields · synced Jul 29, 2026
- FDA UDI 1431f99e-a0d3-4456-90c9-ccd27bb10e5e 36 fields · synced May 30, 2026