PMA P050051S043

Device: ARCHITECT AUSAB, Alinity i Anti-HBs
Applicant: Abbott Laboratories, Inc.
Product code: LOM
Decision date: 2022-04-14
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval for conversion of the microparticle coating process from an automated microparticle processing system to a magnetic separation coating process.

Current openFDA PMA Record#

Device: ARCHITECT AUSAB, Alinity i Anti-HBs
Applicant: Abbott Laboratories, Inc.
PMA number: P050051
Supplement: S043
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2022-04-14
Decision code: APPR
Date received: 2021-09-28
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for conversion of the microparticle coating process from an automated microparticle processing system to a magnetic separation coating process.