HSA · registration DE0503082Instrumentation Laboratory ACL TOP Analysers
SingaporeHematologyClass CInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0503082
- Model name
- ACL TOP 700 LAS; ACL TOP 750 LAS; ACL TOP 500 CTS; ACL TOP 550 CTS; ACL TOP 700 CTS; ACL TOP 750 CTS; ACL TOP 300 CTS; ACL TOP 350 CTS; HemosIL Cleaning Solution; HemosIL Cleaning Agent; HemosIL Rinse Soution; HemosIL Rinse Solution; ACL TOP Cuvettes
- Model identifier
- 00000280030; 00000280035; 00000280040; 00000280045; 00000280050; 00000280055; 00000280060; 00000280065; 0009831700; 0009832700; 0020009700; 0020302400; 0029400100
- Registration date
- May 09, 2019
- Source update date
- June 05, 2024
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 TOP Family 50 Series is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use by health care professionals in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
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.