PMA P230003S011
- Device
- Alinity m HR HPV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S011
- Product code
- MAQ
- Decision date
- 2026-03-12
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval to implement a redesigned Gems Single Tube Reservoir Sensor.
Current openFDA PMA Record#
- Device
- Alinity m HR HPV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S011
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-03-12
- Decision code
- APPR
- Date received
- 2025-12-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to implement a redesigned Gems Single Tube Reservoir Sensor.