UNIVERSAL BIOSENSORS PTY LTD 30106 Xprecia Prime™ PT/INR Test Strips
Company Name
UNIVERSAL BIOSENSORS PTY LTD
Catalog Number
30106
Description
The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determination of International Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.
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Additional Details
Device Identifier
09360136000093
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
No
Is Single Use
Yes
Barcode Mapping
| Unit of Measurement | Eaches | GTIN |
|---|---|---|
| Each | 1 | 09360136000093 |