HSA · registration DE0510009Abbott Alinity i HBsAg Next Qualitative
- Registration number
- DE0510009
- Model name
- 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
- 01R64-1A; 01R6401; 01R6410; 01R6422; 01R6432
- Registration date
- November 06, 2024
- Source update date
- September 23, 2025
- Risk class
- Class D
- Product owner
- Abbott Ireland Diagnostics Division
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
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 address
- Finisklin Business Park, Sligo, Ireland
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.