PMA P160041S035
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S035
- Product code
- PAB
- Decision date
- 2022-12-14
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Approval for the cobas CMV migration from cobas 6800/8800 to the cobas 5800.
Current openFDA PMA Record#
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S035
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2022-12-14
- Decision code
- APPR
- Date received
- 2022-05-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the cobas CMV migration from cobas 6800/8800 to the cobas 5800.