Singapore HSA registration DE0501527
Sekisui Alinity c Salicylate
Singapore·CLASS B IVD·Sekisui Diagnostics P.E.I. Inc.·Registered April 16, 2018Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD