PMA P230003S014

Device: Alinity m HR HPV Assay
Applicant: Abbott Molecular, Inc.
PMA number: P230003
Supplement: S014
Product code: MAQ
Decision date: 2026-06-08
Classification: Microbiology
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval to implement a new nonmetallic Lysis transfer pump that transfers Alinity m Lysis Solution from bulk reagent bottle to the Lysis solution reservoir within the System Solution Drawer of the Alinity m System.

Current openFDA PMA Record#

Device: Alinity m HR HPV Assay
Applicant: Abbott Molecular, Inc.
PMA number: P230003
Supplement: S014
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2026-06-08
Decision code: APPR
Date received: 2026-03-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to implement a new nonmetallic Lysis transfer pump that transfers Alinity m Lysis Solution from bulk reagent bottle to the Lysis solution reservoir within the System Solution Drawer of the Alinity m System.