UNIVERSAL BIOSENSORS PTY LTD

Universal Biosensors Pty Ltd specialises in coagulation-related medical devices. Their primary products include battery-powered point-of-care coagulation analysers, such as the Xprecia Prime™ Coagulation Analyzer, which enable rapid on-site blood testing. They also produce prothrombin time (PT) reagents (e.g., Xprecia Prime™ PT/INR Test Strips) and control materials (e.g., Xprecia™ Systems PT Controls) for quality assurance in coagulation testing. These devices are designed for monitoring conditions like INR levels in patients on anticoagulant therapy.

Universal Biosensors Pty Ltd is based in the United States. Their devices are authorised through the FDA’s 510(k) pathway, which is a premarket submission process for demonstrating substantial equivalence to a legally marketed predicate device. Additionally, their products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance for coagulation analysers, PT reagents, and controls.

Universal Biosensors Pty Ltd’s devices are included in the FDA’s 510(k) registry, which tracks premarket notifications for Class II medical devices like coagulation analysers and PT reagents. Their products are also listed in the FDA’s Unique Device Identifier (UDI) database, which standardises identification for medical devices to improve tracking and regulatory oversight. These listings reflect their compliance with US medical device regulations.

Universal Biosensors Pty Ltd’s coagulation analysers, PT reagents, and control materials fall under Class II classification in the US. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices like these typically require premarket notification (510(k)) to demonstrate equivalence to an existing authorised device.