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Sekisui Diagnostics MULTIGENT Direct LDL Assay - HSA Registration DE0006931

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.

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CLASS B IVD
DE0006931
Sekisui Diagnostics MULTIGENT Direct LDL Assay
HSA Registration Number: DE0006931
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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.

Device 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 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