Instrumentation Laboratory HemosIL Liquid Anti-Xa - HSA Registration DE0508797
Access comprehensive regulatory information for Instrumentation Laboratory HemosIL Liquid Anti-Xa 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 DE0508797 and owned by Instrumentation Laboratory Company. The device was registered on December 29, 2023.
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.
Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP® Family, ACL TOP Family 50 Series† and ACL Elite®/Elite Pro) when used in conjunction with HemosIL Heparin Calibrators. This assay is also intended for the measurement of direct FXa inhibitor concentrations (e.g. rivaroxaban, apixaban) in human citrated plasma on ACL TOP Family and ACL TOP Family 50 Series† systems when used in conjunction with HemosIL Rivaroxaban Calibrators (for rivaroxaban testing) and HemosIL Apixaba Calibrators (for apixaban testing).