PMA P160044S004
- Device
- Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali
- Applicant
- Abbott Molecular
- PMA number
- P160044
- Supplement
- S004
- Product code
- PAB
- Decision date
- 2022-06-09
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Manufacturing scale-up of a kit component.
Current openFDA PMA Record#
- Device
- Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali
- Applicant
- Abbott Molecular
- PMA number
- P160044
- Supplement
- S004
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2022-06-09
- Decision code
- OK30
- Date received
- 2022-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing scale-up of a kit component.