PMA P230003S013

Device: Alinity m HR HPV
Applicant: Abbott Molecular, Inc.
PMA number: P230003
Supplement: S013
Product code: MAQ
Decision date: 2026-05-15
Classification: Microbiology
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for implementing a new Application Specification File (ASF) with improvements to mitigate the risk of carryover by reducing the potential for overflow at sample rack/ sample processing Unit (SPU) and at the AMP reagent tray.

Current openFDA PMA Record#

Device: Alinity m HR HPV
Applicant: Abbott Molecular, Inc.
PMA number: P230003
Supplement: S013
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2026-05-15
Decision code: APPR
Date received: 2026-02-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for implementing a new Application Specification File (ASF) with improvements to mitigate the risk of carryover by reducing the potential for overflow at sample rack/ sample processing Unit (SPU) and at the AMP reagent tray.