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Instrumentation Laboratory ACL Acustar Analyser - HSA Registration DE0502934

Access comprehensive regulatory information for Instrumentation Laboratory ACL Acustar Analyser 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 DE0502934 and owned by Instrumentation Laboratory Company. The device was registered on March 25, 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
DE0502934
Instrumentation Laboratory ACL Acustar Analyser
HSA Registration Number: DE0502934
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Product 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.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0502934
Registration Date
March 25, 2019
Change Notification Approval Date
May 12, 2024
Retention Due Date
March 24, 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 AcuStar Analyzer ACL AcuStar Cuvettes HemosIL ACL AcuStar System Rinse HemosIL ACL AcuStar Triggers HemosIL AcuStar Cleaning Solution
Model Identifier(s)
0009801000 0009801100 0009802200 0009802201 0009802204