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Sekisui Alinity c Salicylate - HSA Registration DE0501527

Access comprehensive regulatory information for Sekisui Alinity c Salicylate 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 DE0501527 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on April 16, 2018.

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
DE0501527
Sekisui Alinity c Salicylate
HSA Registration Number: DE0501527
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Product Description

The Alinity c Salicylate assay is intended for the in vitro quantitative determination of salicylate in human serum or plasma on the Alinity c analyzer. 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
DE0501527
Registration Date
April 16, 2018
Change Notification Approval Date
January 31, 2024
Retention Due Date
April 15, 2026
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)
Alinity c Salicylate Assay File Alinity c Salicylate Calibrator Kit Alinity c Salicylate Reagent Kit
Model Identifier(s)
08P59-1B 08P5901 08P5920