PMA P230003S015
- Device
- Alinity m HR HPV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S015
- Product code
- MAQ
- Decision date
- 2026-07-23
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Requested a site change for the P230003/S015
Current openFDA PMA Record#
- Device
- Alinity m HR HPV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S015
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-07-23
- Decision code
- APPR
- Date received
- 2026-03-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Requested a site change for the P230003/S015