HSA · registration DE0510600Abbott Alinity i HBsAg Next Confirmatory
- Registration number
- DE0510600
- Model name
- 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
- 01R6401; 01R6410; 01R65-1A; 01R6522; 01R6540
- Registration date
- April 16, 2025
- Risk class
- Class D
- Product owner
- Abbott Ireland Diagnostics Division
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
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 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.