Universal Biosensors Xprecia Prime™ PT/INR Test Strips - HSA Registration DE0509812
Access comprehensive regulatory information for Universal Biosensors Xprecia Prime™ PT/INR Test Strips in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509812 and owned by Universal Biosensors Pty Ltd.. The device was registered on September 19, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Xprecia Prime™ PT/INR Test Strips are for use with the Xprecia Prime™ Analyzer for quantitative Prothrombin time testing. The Xprecia Prime™ is for use by healthcare professionals (HCPs). The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 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.