FDA UDI
In Commercial Distribution
🇺🇸 United States
Xprecia™ Systems PT Controls
DI: 09360136000055
·
Model: 90506
·
UNIVERSAL BIOSENSORS PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xprecia™ Systems PT Controls
- Primary DI
- 09360136000055
- Version / Model
- 90506
- Catalog Number
- 90506
- Company Name
- UNIVERSAL BIOSENSORS PTY LTD
- Labeler DUNS
- 742113434
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-27
- Public Version
- 1
- Public Version Date
- 2024-09-04
- Public Version Status
- New
- Public Device Record Key
- ea609599-6329-46fd-8e9e-f6a0f016e8dc
Device Description
Xprecia™ Systems PT Controls is a combination package containing lyophilized normal and abnormal plasma controls to be reconstituted with CaCl2 diluent for use with Xprecia™ Coagulation Systems for PT/INR determinations by professional healthcare providers.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55985 | Prothrombin time (PT) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09360136000055 | GS1 |
Customer Contacts
- Phone
- +12029327918
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151964 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35.6 – 46.4 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit