PMA P110029S030
- Device
- Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit
- Applicant
- Abbott Laboratories
- Product code
- LOM
- Decision date
- 2020-06-05
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Approval of the release of the updated Alinity software.
Current openFDA PMA Record#
- Device
- Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S030
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2020-06-05
- Decision code
- APPR
- Date received
- 2020-03-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of the release of the updated Alinity software.