PMA P160041S041
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S041
- Product code
- PAB
- Decision date
- 2024-07-01
- Classification
- Microbiology
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- to change manufacturing processes
Current openFDA PMA Record#
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S041
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2024-07-01
- Decision code
- OK30
- Date received
- 2024-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change manufacturing processes