PMA P200013S020
- Device
- Alinity m HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S020
- Product code
- MKT
- Decision date
- 2024-07-10
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- to change the manufacturing process for a critical assay component
Current openFDA PMA Record#
- Device
- Alinity m HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S020
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2024-07-10
- Decision code
- OK30
- Date received
- 2024-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change the manufacturing process for a critical assay component