Xprecia™ Systems PT Controls 90506

GUDID 09360136000055

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.

UNIVERSAL BIOSENSORS PTY LTD

Prothrombin time (PT) IVD, control

• Primary Device ID: 09360136000055
• NIH Device Record Key: ea609599-6329-46fd-8e9e-f6a0f016e8dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xprecia™ Systems PT Controls
• Version Model Number: 90506
• Catalog Number: 90506
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09360136000055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151964

FDA Product Code

• GGN: Plasma, Coagulation Control

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

Devices Manufactured by UNIVERSAL BIOSENSORS PTY LTD

• 09360136000055 - Xprecia™ Systems PT Controls: 2024-09-04Xprecia™ 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.
• 09360136000055 - Xprecia™ Systems PT Controls: 2024-09-04 Xprecia™ Systems PT Controls is a combination package containing lyophilized normal and abnormal plasma controls to be reconst
• 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