PMA P110037S055
- Device
- COBAS AmpliPrep/COBAS TaqMan CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S055
- Product code
- PAB
- Decision date
- 2021-03-09
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Move the manufacturing site of critical sub-assembly.
Current openFDA PMA Record#
- Device
- COBAS AmpliPrep/COBAS TaqMan CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S055
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2021-03-09
- Decision code
- OK30
- Date received
- 2021-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move the manufacturing site of critical sub-assembly.