PMA P210022S005
- Device
- Alinity m CMV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S005
- Product code
- PAB
- Decision date
- 2023-06-16
- Classification
- Microbiology
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Approval to add a sheet metal shroud around the Alinity m System Tip Chute Assembly.
Current openFDA PMA Record#
- Device
- Alinity m CMV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S005
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2023-06-16
- Decision code
- APPR
- Date received
- 2023-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add a sheet metal shroud around the Alinity m System Tip Chute Assembly.