Singapore HSA registration DE0008333
Sentinel Diagnostics Lambda Light Chains Assay
Singapore·CLASS C IVD·Sentinel CH. SpA·Registered January 30, 2012Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0008333
- Registration Date
- January 30, 2012
- Change Notification Approval Date
- January 12, 2023
- Retention Due Date
- January 29, 2026
Product description
The MULTIGENT Lambda Light Chains assay is intended for the quantitative immunoturbidimetric determination of the bound and free lambda light chains in serum or plasma on the ARCHITECT c Systems.
Product Owner
- Name
- Sentinel CH. SpA
- Short Name
- SENTINEL CH. SpA
- Address
- Via Robert Koch, 2, Milan 20152, ITALY
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)
- Lambda light Chains Plasmaproteins Cal 3x Immuno Control 1 Immuno Control 2 Immuno Control Set Lambda light Chains
- Model Identifier(s)
- 4P80-30 6K31-10 6K32-20 6K32-21 6K32-22 6K96-20
About this record
Access comprehensive regulatory information for Sentinel Diagnostics Lambda Light Chains Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0008333 and owned by Sentinel CH. SpA. The device was registered on January 30, 2012.
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 C IVD