PMA P160041S031
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S031
- Product code
- PAB
- Decision date
- 2020-10-07
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Approval for changes being effected to update hazard labeling.
Current openFDA PMA Record#
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S031
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2020-10-07
- Decision code
- APPR
- Date received
- 2020-09-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes being effected to update hazard labeling.