PMA P110029S038
- Device
- ARCHITECT HBsAg Qualitative/Confirmatory/Alinity i HBsAg Qualitative II/Confirmatory
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S038
- Product code
- LOM
- Decision date
- 2022-09-30
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Change in test method used in the manufacture of an assay component.
Current openFDA PMA Record#
- Device
- ARCHITECT HBsAg Qualitative/Confirmatory/Alinity i HBsAg Qualitative II/Confirmatory
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S038
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-09-30
- Decision code
- OK30
- Date received
- 2022-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in test method used in the manufacture of an assay component.