HSA · registration DE0508797Instrumentation Laboratory HemosIL Liquid Anti-Xa
- Registration number
- DE0508797
- Model name
- HemosIL Rivaroxaban Calibrators; HemosIL Rivaroxaban Controls; HemosIL Apixaban Calibrators; HemosIL Apixaban Controls; HemosIL LMW Heparin Controls; HemosIL UF Heparin Controls; HemosIL Heparin Calibrators; HemosIL Liquid Anti-Xa; HemosIL Liquid Anti-Xa
- Model identifier
- 0020013600; 0020013700; 0020014200; 0020014300; 0020300200; 0020300300; 0020300600; 0020302600; 0020302601
- Registration date
- December 29, 2023
- Risk class
- Class C
- Product owner
- Instrumentation Laboratory Company
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
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).
- Product owner address
- 180 Hartwell Road, Bedford MA 01730, United States of America, United States
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.