Singapore HSA registration DE0510009
Abbott Alinity i HBsAg Next Qualitative
Singapore·CLASS D IVD·Abbott Ireland Diagnostics Division·Registered November 06, 2024Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510009
- Registration Date
- November 06, 2024
- Retention Due Date
- November 05, 2025
Product description
The HBsAg Next Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heart-beating), on the Alinity i system. The HBsAg Next Qualitative assay is intended to be used as an aid in the diagnosis of Hepatitis B virus (HBV) infection and as a screening test to prevent transmission of HBV to recipients of blood, blood components, cells, tissue, and organs.
Product Owner
- Short Name
- Abbott Ireland Diagnostics Division
- Address
- Finisklin Business Park, Sligo, IRELAND
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 i HBsAg Next Qualitative Assay File HBsAg Next Qualitative Calibrators HBsAg Next Qualitative Controls HBsAg Next Qualitative Reagent Kit HBsAg Next Qualitative Reagent Kit
- Model Identifier(s)
- 01R64-1A 01R6401 01R6410 01R6422 01R6432
About this record
Access comprehensive regulatory information for Abbott Alinity i HBsAg Next Qualitative 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 DE0510009 and owned by Abbott Ireland Diagnostics Division. The device was registered on November 06, 2024.
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