HSA · registration DE0508285Instrumentation Laboratory HemosIL Direct Thrombin Inhibitor
SingaporeHematologyClass CInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0508285
- Model name
- HemosIL Dabigatran Calibrators; HemosIL Dabigatran Controls; HemosIL Direct Thrombin Inhibitor Assay
- Model identifier
- 0020013400; 0020013500; 0020302800
- Registration date
- July 12, 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
The HemosIL Direct Thrombin Inhibitor (DTI) Assay is an in vitro diagnostic assay for the quantitative determination of the Direct Thrombin Inhibitor Dabigatran in citrated human plasma on the ACL TOP Family of analyzers. The product is intended to be used for the measurement of active Dabigatran levels in situations where measurement is warranted.
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.