Singapore HSA registration DE0006858
Sekisui Diagnostics Salicylate Assay
Singapore·CLASS B IVD·Sekisui Diagnostics P.E.I. Inc.·Registered May 26, 2011Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD