PMA P110037S042
- Device
- COBAS AmpliPrep/COBAS TaqMan CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S042
- Product code
- PAB
- Decision date
- 2018-12-07
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Add a new filter in manufacturing procedures.
Current openFDA PMA Record#
- Device
- COBAS AmpliPrep/COBAS TaqMan CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S042
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2018-12-07
- Decision code
- OK30
- Date received
- 2018-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new filter in manufacturing procedures.