PMA P200013S026

Device: Alinity m HBV
Applicant: Abbott Molecular, Inc.
PMA number: P200013
Supplement: S026
Product code: MKT
Decision date: 2025-09-24
Classification: Microbiology
Generic name: Hepatitis Viral B DNA Detection
Approval order statement: Approval for creating an Alinity m Systems Liner (“Liner”) as a containment device placed underneath the Alinity m System to catch fluids that may leak from the reagent storage and dispense portions of the instrument.

Current openFDA PMA Record#

Device: Alinity m HBV
Applicant: Abbott Molecular, Inc.
PMA number: P200013
Supplement: S026
Product code: MKT
Generic name: Hepatitis Viral B DNA Detection
Decision date: 2025-09-24
Decision code: APPR
Date received: 2025-07-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for creating an Alinity m Systems Liner (“Liner”) as a containment device placed underneath the Alinity m System to catch fluids that may leak from the reagent storage and dispense portions of the instrument.