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Singapore HSA registration DE0506449

Instrumentation Laboratory HemosIL AcuStar ADAMTS13 Activity

Singapore flagSingapore·CLASS B IVD·Instrumentation Laboratory Company·Registered December 06, 2021
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0506449
Registration Date
December 06, 2021
Retention Due Date
December 05, 2025
Product description
The HemosIL AcuStar ADAMTS13 Activity is a quantitative, fully automated, chemiluminescent immunoassay (CIA) for the measurement of ADAMTS13 Activity. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL AcuStar® in a laboratory setting by healthcare professionals. The assay results aid in the diagnosis and monitoring of Thrombotic Thrombocytopenic Purpura (TTP). The results should be used in conjunction with other clinical and laboratory findings. For use in adult population. For prescription use only
Product Owner
Name
Instrumentation Laboratory Company
Short Name
Instrumentation Laboratory Company
Address
180 Hartwell Road, Bedford MA 01730, United States of America, 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 AcuStar ADAMTS13 Activity HemosIL AcuStar ADAMTS13 Activity Reagent Cartridge HemosIL AcuStar ADAMTS13 Act 1mL Calibrator 0 HemosIL AcuStar ADAMTS13 Act 1mL Calibrator 1 HemosIL AcuStar ADAMTS13 Act 1mL Calibrator 2 HemosIL AcuStar ADAMTS13 Act 1.8mL Buffer HemosIL AcuStar VWF Controls
Model Identifier(s)
9802048 9802049 9802050 9802051 9802052 9802053 9802119
About this record

Access comprehensive regulatory information for Instrumentation Laboratory HemosIL AcuStar ADAMTS13 Activity in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506449 and owned by Instrumentation Laboratory Company. The device was registered on December 06, 2021.

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 B IVD