PMA P200013S021
- Device
- Alinity m HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S021
- Product code
- MKT
- Decision date
- 2024-09-13
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- 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 HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S021
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- 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.