Singapore HSA registration DE0006931
Sekisui Diagnostics MULTIGENT Direct LDL Assay
Singapore·CLASS B IVD·Sekisui Diagnostics P.E.I. Inc.·Registered June 08, 2011Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0006931
- Registration Date
- June 08, 2011
- Change Notification Approval Date
- August 17, 2023
- Retention Due Date
- December 31, 2025
Product description
The MULTIGENT Direct LDL assay is used for the direct, quantitative determination of low-density lipoprotein (LDL) cholesterol in human serum or plasma on the ARCHITECT c Systems.
Product Owner
- Short Name
- Sekisui Diagnostics P.E.I. Inc.
- Address
- 70 Watts Ave., Charlottetown, Prince Edward Island, Canada C1E 2B9, CANADA
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- MULTIGENT Direct LDL Calibrator Kit (Low density lipoprotein calibrator) MULTIGENT Direct LDL Reagent (Low density lipoprotein kit)
- Model Identifier(s)
- 1E31-02 1E31-20
About this record
Access comprehensive regulatory information for Sekisui Diagnostics MULTIGENT Direct LDL Assay 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 DE0006931 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on June 08, 2011.
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