PMA P110029

Device: ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory
Applicant: Abbott Laboratories
PMA number: P110029
Supplement: S041
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 HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory
Applicant: Abbott Laboratories
PMA number: P110029
Supplement: S052
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