PMA P050051
- Device
- ARCHITECT AUSAB; Alinity i Anti-HBs
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S049
- Product code
- LOM
- Decision date
- 2025-04-03
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- the implementation of an additional manufacturing room
Current openFDA PMA Record#
- Device
- ARCHITECT AUSAB; Alinity i Anti-HBs
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S061
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2025-04-03
- Decision code
- OK30
- Date received
- 2025-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the implementation of an additional manufacturing room