Singapore HSA registration DE0501345
Sekisui Alinity c Direct LDL
Singapore·CLASS B IVD·Sekisui Diagnostics P.E.I. Inc.·Registered March 09, 2018Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0501345
- Registration Date
- March 09, 2018
- Change Notification Approval Date
- May 25, 2023
- Retention Due Date
- March 08, 2026
Product description
The Alinity c Direct LDL assay is used for the direct, quantitative determination of low-density lipoprotein (LDL) cholesterol in human serum or plasma on the Alinity c analyzer.
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 Direct LDL Assay File Alinity c Direct LDL Reagent Kit Alinity c Direct LDL Reagent Kit Alinity c Lipid Multiconstituent Calibrator Kit
- Model Identifier(s)
- 07P71-1A 07P7120 07P7123 09P1403
About this record
Access comprehensive regulatory information for Sekisui Alinity c Direct LDL 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 DE0501345 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on March 09, 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