PMA P110037S059
- Device
- COBAS® AmpliPrep/COBAS® TaqMan® CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S059
- Product code
- PAB
- Decision date
- 2023-08-23
- Classification
- Microbiology
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Change manufacturing tolerances for a component.
Current openFDA PMA Record#
- Device
- COBAS® AmpliPrep/COBAS® TaqMan® CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S059
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2023-08-23
- Decision code
- OK30
- Date received
- 2023-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change manufacturing tolerances for a component.