PMA P230003S004
- Device
- Alinity m HR HPV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S004
- Product code
- MAQ
- Decision date
- 2024-09-13
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval to add AMP Detect insert bar on the Amplification Detection Unit (ADU) ejection bar of the Alinity m System.
Current openFDA PMA Record#
- Device
- Alinity m HR HPV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P230003
- Supplement
- S004
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2024-09-13
- Decision code
- APPR
- Date received
- 2024-06-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add AMP Detect insert bar on the Amplification Detection Unit (ADU) ejection bar of the Alinity m System.