PMA P200013S022
- Device
- Alinity m HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S022
- Product code
- MKT
- Decision date
- 2024-09-05
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval to the request to include sample tube label requirements and edits to the the instrument Operations Manual Addendum.
Current openFDA PMA Record#
- Device
- Alinity m HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S022
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2024-09-05
- Decision code
- APPR
- Date received
- 2024-08-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to the request to include sample tube label requirements and edits to the the instrument Operations Manual Addendum.