PMA P210022S011
- Device
- Alinity m CMV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S011
- Product code
- PAB
- Decision date
- 2024-07-10
- Classification
- Microbiology
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- to change the manufacturing process for a critical assay component
Current openFDA PMA Record#
- Device
- Alinity m CMV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S011
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- 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