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Singapore HSA registration DE0508285

Instrumentation Laboratory HemosIL Direct Thrombin Inhibitor

Singapore flagSingapore·CLASS C IVD·Instrumentation Laboratory Company·Registered July 12, 2023
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0508285
Registration Date
July 12, 2023
Retention Due Date
July 11, 2025
Product description
The HemosIL Direct Thrombin Inhibitor (DTI) Assay is an in vitro diagnostic assay for the quantitative determination of the Direct Thrombin Inhibitor Dabigatran in citrated human plasma on the ACL TOP Family of analyzers. The product is intended to be used for the measurement of active Dabigatran levels in situations where measurement is warranted.
Product Owner
Name
Instrumentation Laboratory Company
Short Name
Instrumentation Laboratory Company
Address
180 Hartwell Road, Bedford MA, 01730-2443, UNITED STATES
Registrant
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
Model Name(s)
HemosIL Dabigatran Calibrators HemosIL Dabigatran Controls HemosIL Direct Thrombin Inhibitor Assay
Model Identifier(s)
20013400 20013500 20302800
About this record

Access comprehensive regulatory information for Instrumentation Laboratory HemosIL Direct Thrombin Inhibitor 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 DE0508285 and owned by Instrumentation Laboratory Company. The device was registered on July 12, 2023.

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