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Sentinel Diagnostics Kappa Light Chains Assay - HSA Registration DE0008331

Access comprehensive regulatory information for Sentinel Diagnostics Kappa 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 DE0008331 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.

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CLASS C IVD
DE0008331
Sentinel Diagnostics Kappa Light Chains Assay
HSA Registration Number: DE0008331
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Product Description

The MULTIGENT Kappa Light Chains assay is intended for the quantitative immunoturbidimetric determination of the bound and free kappa light chains in serum or plasma on the ARCHITECT c Systems.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0008331
Registration Date
January 30, 2012
Change Notification Approval Date
January 12, 2023
Retention Due Date
January 29, 2026
Product Owner
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)
Plasmaproteins Cal 3x Immuno Control 1 Immuno Control 2 Immuno Control Set Kappa light chains
Model Identifier(s)
6K31-10 6K32-20 6K32-21 6K32-22 6K96-30