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Singapore HSA registration DE0510600

Abbott Alinity i HBsAg Next Confirmatory

Singapore flagSingapore·CLASS D IVD·Abbott Ireland Diagnostics Division·Registered April 16, 2025
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0510600
Registration Date
April 16, 2025
Retention Due Date
April 15, 2026
Product description
The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) used for the confirmation of the presence of Hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heartbeating), by means of specific antibody neutralization on the Alinity i system. The HBsAg Next Confirmatory assay is intended to be used for the confirmation of samples found to be repeatedly reactive by the HBsAg Next Qualitative assay.
Product Owner
Name
Abbott Ireland Diagnostics Division
Short Name
Abbott Ireland Diagnostics Division
Address
Finisklin Business Park, Sligo, IRELAND
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 i HBsAg Next Qualitative Calibrators Alinity i HBsAg Next Qualitative Controls Alinity i HBsAg Next Confirmatory Assay File Alinity i HBsAg Next Confirmatory Reagent Kit Alinity i HBsAg Next Confirmatory Manual Diluent
Model Identifier(s)
01R6401 01R6410 01R65-1A 01R6522 01R6540
About this record

Access comprehensive regulatory information for Abbott Alinity i HBsAg Next Confirmatory 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 DE0510600 and owned by Abbott Ireland Diagnostics Division. The device was registered on April 16, 2025.

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