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Instrumentation Laboratory ACL TOP Analysers - HSA Registration DE0503082

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.

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CLASS C IVD
DE0503082
Instrumentation Laboratory ACL TOP Analysers
HSA Registration Number: DE0503082
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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.

Device 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 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