PMA P160041S022
- Device
- Cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S022
- Product code
- PAB
- Decision date
- 2019-06-06
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Scale up for manufacturing of a sub-bulk reagent and subsequent changes to filling operations for a critical component.
Current openFDA PMA Record#
- Device
- Cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S022
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2019-06-06
- Decision code
- OK30
- Date received
- 2019-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Scale up for manufacturing of a sub-bulk reagent and subsequent changes to filling operations for a critical component.