PMA P200013S027
- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S027
- Product code
- MKT
- Decision date
- 2025-10-17
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval to release software Alinity m System Software version 1.9.1., which incorporates all changes, in the US for a mandatory customer software update.
Current openFDA PMA Record#
- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S027
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2025-10-17
- Decision code
- APPR
- Date received
- 2025-09-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to release software Alinity m System Software version 1.9.1., which incorporates all changes, in the US for a mandatory customer software update.