HSA · registration DE0504503Instrumentation Laboratory HemosIL APTT-SP
SingaporeHematologyClass CInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0504503
- Model name
- HemosIL Factor Diluent; HemosIL Normal Control ASSAYED; HemosIL Low Abnormal Control ASSAYED; HemosIL High Abnormal Control ASSAYED; HemosIL Calibration Plasma; HemosIL APTT-SP (liquid)
- Model identifier
- 0009757600; 0020003110; 0020003210; 0020003310; 0020003700; 0020006300
- Registration date
- May 22, 2020
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
For the in vitro determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.
Additional source fields
- Product owner address
- 180 Hartwell Road, Bedford, MA 01730, 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.