Procleix Xpress® System
Basic Information
- Brand Name
- Procleix Xpress® System
- Primary DI
- 00866489000005
- Version / Model
- 30055067
- Catalog Number
- 30055067
- Company Name
- GRIFOLS DIAGNOSTIC SOLUTIONS INC.
- Labeler DUNS
- 056570085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- 1431f99e-a0d3-4456-90c9-ccd27bb10e5e
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMH | Software, Blood Bank, Stand Alone Products | Hematology | 864.9165 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37926 | Electronic pipette | An electronic, hand-held instrument intended to be used to withdraw, transfer, and inject specific volumes of fluid materials typically from one laboratory container to another, during an in vitro diagnostic procedure. It is typically in the form of a single-channel or multichannel liquid handling device used to deliver fluid materials into one receptacle or several receptacles simultaneously. It may be factory pre-set to deliver a specific volume or enable user-specified volumes within a useful range, visible on an electronic display. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00866489000005 | GS1 |
Customer Contacts
- Phone
- 1-800-452-6877
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK140150 | 0 |