HSA · registration DE0508543Instrumentation Laboratory HemosIL Heparin
SingaporeHematologyClass CInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0508543
- Model name
- HemosIL Heparin; HemosIL LMW Heparin Controls; HemosIL UF Heparin Controls; HemosIL Heparin Calibrators
- Model identifier
- 0020009400; 0020300200; 0020300300; 0020300600
- Registration date
- October 05, 2023
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Instrumentation Laboratory Company
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
Official description
Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on the IL Coagulation Systems.
Additional source fields
- Product owner address
- 180 Hartwell Road, Bedford MA, 01730-2443, United States
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
About this record
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.