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Singapore HSA registration DE0502711

Instrumentation Laboratory HemosIL Protein S Activity

Singapore flagSingapore·CLASS B IVD·Instrumentation Laboratory Company·Registered January 23, 2019
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0502711
Registration Date
January 23, 2019
Change Notification Approval Date
June 07, 2019
Retention Due Date
January 22, 2026
Product description
Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma on the ACL TOP® Family, ACL ELITE®/ELITE PRO/8/9/10000, ACL Advance and ACL Classic (100-7000) Systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.
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 Factor Diluent HemosIL Normal Control ASSAYED HemosIL Low Abnormal Control HemosIL Calibration Plasma HemosIL Protein S Activity
Model Identifier(s)
0009757600 0020003110 0020003210 0020003700 0020302000
About this record

Access comprehensive regulatory information for Instrumentation Laboratory HemosIL Protein S 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 DE0502711 and owned by Instrumentation Laboratory Company. The device was registered on January 23, 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 B IVD