- Device
- Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S029
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2020-01-07
- Decision code
- APPR
- Date received
- 2019-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for migration of the ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Calibrators, ARCHITECT HBsAg Qualitative Confirmatory, and ARCHITECT HBsAg Controls onto the Alinity i Analyzer. The device, as modified, will be marketed under the trade names Alinity i HBsAg Qualitative II Reagent Kit, Alinity i HBsAg Qualitative II Calibrators, Alinity i HBsAg Qualitative II Confirmatory Reagent Kit, and Alinity I HBsAg Qualitative II Controls.