HSA · registration DE0504050Instrumentation Laboratory HemosIL SynthAFax
SingaporeHematologyClass CInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0504050
- Model name
- HemosIL Factor Diluent; HemosIL Normal Control ASSAYED; HemosIL Low Abnormal Control ASSAYED; HemosIL High Abnormal Control ASSAYED; HemosIL Calibration Plasma; HemosIL SynthAFax
- Model identifier
- 0009757600; 0020003110; 0020003210; 0020003310; 0020003700; 0020007400
- Registration date
- January 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
Intended for in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation Systems, for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Additional source fields
- 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
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.