Xprecia Prime™ Coagulation Analyzer 90306

GUDID 09360136000086

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.

UNIVERSAL BIOSENSORS PTY LTD

Coagulation analyser IVD, point-of-care, battery-powered

• Primary Device ID: 09360136000086
• NIH Device Record Key: d03c1b06-3c5c-43d2-8012-4aba5a0a5de7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xprecia Prime™ Coagulation Analyzer
• Version Model Number: A0297
• Catalog Number: 90306
• Company DUNS: 742113434
• Company Name: UNIVERSAL BIOSENSORS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com
• Phone: +12029327918
• Email: XpreciaHelp@universalbiosensors.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	09360136000079 [Primary]
GS1	09360136000086 [Package]; Contains: 09360136000079; Package: Carton [1 Units]; In Commercial Distribution

FDA Product Code

• GJS: Test, Time, Prothrombin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-04
• Device Publish Date: 2024-08-27

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• 09360136000086 - Xprecia Prime™ Coagulation Analyzer: 2024-09-04The 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.
• 09360136000086 - Xprecia Prime™ Coagulation Analyzer: 2024-09-04 The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the
• 09360136000093 - Xprecia Prime™ PT/INR Test Strips: 2024-09-04 The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the