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Singapore HSA registration DE0506093

Abbott Alinity s Syphilis

Singapore flagSingapore·CLASS D IVD·Abbott GmbH·Registered August 20, 2021
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0506093
Registration Date
August 20, 2021
Change Notification Approval Date
August 28, 2024
Retention Due Date
August 19, 2025
Product description
The Alinity s Syphilis assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to Treponema pallidum (T pallidum, TP) in human serum and plasma, including specimens collected post-mortem (non-heart-beating) on the Alinity s System. The Alinity s Syphilis assay is intended to be used as an aid in the diagnosis of Syphilis infection and as a screening test to prevent transmission of T pallidum to recipients of blood, blood components, cells, tissue and organs.
Product Owner
Name
Abbott GmbH
Short Name
Abbott GmbH
Address
Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
Alinity s Syphilis Assay File Alinity s Syphilis Calibrator Kit Alinity s Syphilis Assay Control Kit Alinity s Syphilis Release Control Kit Alinity s Syphilis Reagent Kit
Model Identifier(s)
06P09-1B 06P0902 06P0910 06P0912 06P0955
About this record

Access comprehensive regulatory information for Abbott Alinity s Syphilis in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0506093 and owned by Abbott GmbH. The device was registered on August 20, 2021.

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 D IVD