Singapore HSA registration DE0503082
Instrumentation Laboratory ACL TOP Analysers
Singapore·CLASS C IVD·Instrumentation Laboratory Company·Registered May 09, 2019Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0503082
- Registration Date
- May 09, 2019
- Change Notification Approval Date
- June 05, 2024
- Retention Due Date
- May 08, 2026
Product 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.
Product Owner
- Short Name
- Instrumentation Laboratory Company
- Address
- 180 Hartwell Road, Bedford MA 01730, United States of America, UNITED STATES
Registrant
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
- Model Name(s)
- 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(s)
- 00000280030 00000280035 00000280040 00000280045 00000280050 00000280055 00000280060 00000280065 0009831700 0009832700 0020009700 0020302400 0029400100
About this record
Access comprehensive regulatory information for Instrumentation Laboratory ACL TOP Analysers in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0503082 and owned by Instrumentation Laboratory Company. The device was registered on May 09, 2019.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD