Rally #41-1-3306
Universal BioSensors #91306
Xpreica Prime Starter Pack (1/KT)
Promotional Bundle: (1) Analyzer (90306), (100) Test Strips (30106), and (1) Box of Quality Controls (90506), CLIA Waived
Xpreica Prime™ Promotional Starter Pack Bundle
Bundle Offer Valid Through December 31, 2025- Eject button for safe handling
- Operator ID entry with lockout features
- Wi-Fi and wired connection
- Rechargeable battery cell
- Results in less than one minute
- User friendly software and touchscreen
- Automatic calibration – no reagents needed
- Enables quick and precise results in less than one minute.
- Enables automatic QC check with embeded barcode data.
- Minimal blood sample (~8μL) reduces discomfort while maintaining accuracy.
- Two ranges: normal (LQC PT1) and therapeutic (LQC PT2)
- Lyophilized
Xprecia Prime™ PT/INR Test Strips are specifically designed for use with the Xprecia Prime™ Coagulation Analyzer and are intended to determine the International Normalized Ratio (INR) for monitoring anticoagulation therapy with warfarin in fresh capillary whole blood. This test is critical for assessing blood coagulation and managing patients on anticoagulant medication.
The Xprecia™ Liquid Quality Controls (LQC) kit is designed for use with Xprecia™ Stride and Prime analyzers to check precision and accuracy in prothrombin time (PT) testing. It includes both normal and therapeutic controls and is be used with the Xprecia Prime™ PT/INR Test Strips and Xprecia Stride® PT/INR Test Strips in conjunction with their corresponding analyzers. The controls are lyophilized plasma that must be reconstitutioned before medical professionals may utilize it for PT/INR measurements.
Important Notes:
- Restricted Product: Rx Only - Current Valid Medical License Required.
- For professional in-vitro diagnostic use.
- Device is not for self-testing.
- This item is non-returnable. Please verify your ordering information before making a purchase.
- Analyzer power supply is for indoor use only.
- CLIA Waived when use with Xprecia Prime™ PT/INR Test Strips.
- Product controls requires refrigeration. Do not freeze!
- Use reconstituted control solutions stored at 2–8°C (36–46°F) within 60 minutes (closed vial), and those stored at 15–25°C ( 59–77°F) within 25 minutes (closed vial).
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
Rally # | 41-1-3306 |
Manufacturer # | 91306 |
Brand | Xprecia Prime™ |
Manufacturer | Universal BioSensors |
Country of Origin | Australia |
Contents | (1) Analyzer (90306), (100) Test Strips (30106), and (1) Box of Quality Controls (90506) |
Purchase Program Type | Promotion Starter Kit |
Warranty | Analyzer: 1 Year, Parts and Labor |
Xprecia Prime™ Coagulation Analyzer
Rally # | 41-1-3316 |
Manufacturer # | 90306 |
510(k) # | K230802 |
Brand | Xprecia Prime™ |
Manufacturer | Universal BioSensors |
Country of Origin | Australia |
Analyzer Type | Hand-Held |
Application | Coagulation Analyzer |
CLIA Classification | CLIA Waived |
Display Type | Touchscreen |
Reading Type | Machine Read |
Readout Type | Digital, Comma-Delimited Format (CSV) |
Operating Principle/Technology | Electrochemical Rechnology with Amperometric (Electric Current) Detection of Thrombin Activity |
Specimen Type | Capillary Whole Blood |
Power Source | Battery Operated / USB Connection (AC) |
Battery Type | Rechargeable |
Time to Results | Less Than One Minute |
Results Storage | 1000 Patient Results |
User Interface | Barcode or Touchscreen Keyboard |
Warranty | 1 Year, Parts and Labor |
For additional specification information, please go here: 41-1-3316.
Xprecia Prime™ PT/INR Test Strips
Rally # | 41-1-3106 |
Manufacturer # | 30106 |
Brand | Xprecia Prime™ |
Manufacturer | Universal BioSensors |
Country of Origin | Australia |
Application | Coagulation Test Strip |
CLIA Classification | CLIA Waived |
For Use With | Xprecia Prime™ Coagulation Analyzer |
Number of Tests | 25 Tests |
Test Type | Blood Coagulation Test |
Test Name | Prothrombin Time Test (PT/INR) |
Test Strip Reagents | Human Recombinant Thromboplastin |
Sample Type | Capillary Whole Blood |
Reading Type | Machine Read |
Blood Sample Volume | 8 µL Sample |
Time to results | Less Than One Minute |
Test Strip Use Time | 10 minutes |
For additional specification information, please go here: 41-1-3106.
Xprecia™ Liquid Quality Controls
Rally # | 41-1-3506 |
Manufacturer # | 90506 |
Manufacturer | Universal Biosensors |
Country of Origin | Unknown |
Application | Control Set |
Container Type | Vial |
For Use With | Xprecia™ Stride & Xprecia™ Prime Coagulation Analyzer & their Corresponding Strips |
Form | Lyophilized, Liquid (Diluent) |
Levels | Normal (LQC PT1) / Therapeutic (LQC PT2) |
Test Category | Hematology |
Test Type | Coagulation |
Test Name | PT / INR Test (Prothrombin Time Test) |
Volume | 8 x 1 mL |
Sterility | Sterile |
Storage Requirements | Requires Refrigeration: 2–8°C (35.6–46.4°F) |
For additional specification information, please go here: 41-1-3506.
Configurations
Produce Code | Product Name | Pack Contents |
90306 | Xprecia Prime™ Coagulation Analyzer | 1 x analyzer and accessories |
30106 | Xprecia Prime™ PT/INR Test Strips | 4 x vials and 25 strips per vial |
90506 | Xprecia™ Systems PT Controls | 4 x level 1 controls and 4 x level 2 controls |
91306 | Xpreica Prime™ Starter Pack | 1 x Analyzer (90306) 4 x 25 Test Strips (30106) 1 Box of Quality Controls (90506) |
Package Contents - Xprecia Prime™ Coagulation Analyzer
- 1 x Xprecia Prime™ Analyzer
- 1 x Charger
- 1 x Replacement cap
- 1 x Power supply (including USB cable & 4 sockets)
- 1 x User guide
- 2 x Quick start guide for:
- 1 x patient test
- 1 x LQC test
Package Contents - Xprecia Prime™ PT/INR Test Strips
4 vials of strips with 25 strips per vial.
Package Contents - Xprecia™ Liquid Quality Controls
- 4 x PT Control 1
- 4 x PT Control 2
- 8 x 1.0 mL CaCl2 Diluent
- 8 x Transfer pipettes
- 1 x Instructions for Use
Accessories and Parts
Currently Unavailable
Documentation Links
Xprecia Prime™ Coagulation Analyzer Xprecia Prime™ PT/INR Test Strips Xprecia™ Liquid Quality Controls
Video Links
Reimbursements Information
This product may be reimbursable, depending on various factors including current law and policies. Rally Inc. does not handle these reimbursements; instead, each reimbursement is handled solely between you, the customer, and the manufacturer, Universal Biosensors. Rally Inc. does not oversee these reimbursements. To check eligibility and get your reimbursements, please follow the manufacturer's reimbursement instructions.
Below are the reimbursement informations provided by Universal Biosensors as of March 3, 2025:
Xprecia Prime™ PT/INR Test Strips CPT Code:
85610QW (Fingerstick)
93793 (Global)
Please note that Rally Inc. is not responsible for the accuracy of reimbursement information provided by the manufacturer. In addition, this information might change as time passes. Please contact Universal Biosensors for the latest reimbursement information. You can contact them here.