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Sekisui Diagnostics Salicylate Assay - HSA Registration DE0006858

Access comprehensive regulatory information for Sekisui Diagnostics Salicylate 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 DE0006858 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on May 26, 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
DE0006858
Sekisui Diagnostics Salicylate Assay
HSA Registration Number: DE0006858
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Product Description

The Salicylate assay is intended for the in vitro quantitative determination of salicylate in human serum or plasma on the ARCHITECT c Systems. Salicylate measurements are used to aid in the diagnosis and monitoring of patients suspected of salicylate toxicity. For laboratory professional use only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0006858
Registration Date
May 26, 2011
Change Notification Approval Date
December 05, 2023
Retention Due Date
December 31, 2025
Product Owner
Address
70 Watts Avenue, Charlottetown, Prince Edward Island 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)
Salicylate Calibrator Salicylate Reagent
Model Identifier(s)
3K01-01 3K01-20