Singapore HSA registration DE0508797
Instrumentation Laboratory HemosIL Liquid Anti-Xa
Singapore·CLASS C IVD·Instrumentation Laboratory Company·Registered December 29, 2023Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0508797
- Registration Date
- December 29, 2023
- Retention Due Date
- December 28, 2025
Product description
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
- Short Name
- Instrumentation Laboratory Company
- Address
- 180 Hartwell Road, Bedford MA 01730, United States of America, UNITED STATES
Registrant
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
- Model Name(s)
- 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(s)
- 20013600 20013700 20014200 20014300 20300200 20300300 20300600 20302600 20302601
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD