PMA P210022S013
- Device
- Alinity m CMV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S013
- Product code
- PAB
- Decision date
- 2024-09-05
- Classification
- Microbiology
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- 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 CMV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P210022
- Supplement
- S013
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- 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.