- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S005
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2021-06-01
- Decision code
- APPR
- Date received
- 2021-04-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to release the software version 1.6.2 in the United States, incorporating into the Alinity m System Software version 1.6.0, version 1.6.1 and 1.6.2, which are currently released outside the US.