PMA P200013S018
- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S018
- Product code
- MKT
- Decision date
- 2024-02-05
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Abbott Molecular Inc. seeks approval to release software version 1.8.0 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
- S018
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2024-02-05
- Decision code
- APPR
- Date received
- 2023-11-15
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Abbott Molecular Inc. seeks approval to release software version 1.8.0 in the US for a mandatory customer software update.