PMA P230003S007
- Device
- Alinity m HR HPV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S007
- Product code
- MAQ
- Decision date
- 2025-04-18
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- an alternate to the current manufacturing process
Current openFDA PMA Record#
- Device
- Alinity m HR HPV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S007
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2025-04-18
- Decision code
- OK30
- Date received
- 2025-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate to the current manufacturing process