HSA · registration DE0502934Instrumentation Laboratory ACL Acustar Analyser
SingaporeHematologyClass CInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0502934
- Model name
- ACL AcuStar Analyzer; ACL AcuStar Cuvettes; HemosIL ACL AcuStar System Rinse; HemosIL ACL AcuStar Triggers; HemosIL AcuStar Cleaning Solution
- Model identifier
- 0009801000; 0009801100; 0009802200; 0009802201; 0009802204
- Registration date
- March 25, 2019
- Source update date
- August 20, 2025
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 ACL AcuStar is an automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology.
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.