PMA P210003

Device: ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N
Applicant: Abbott Laboratories
PMA number: P210003
Supplement: S005
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 Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N
Applicant: Abbott Laboratories
PMA number: P210003
Supplement: S013
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