PMA P160041S033
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S033
- Product code
- PAB
- Decision date
- 2021-06-02
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Approval for an update to the hazard information on the product labeling for kits on the cobas 6800/8800 Systems.
Current openFDA PMA Record#
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P160041
- Supplement
- S033
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2021-06-02
- Decision code
- APPR
- Date received
- 2021-05-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to the hazard information on the product labeling for kits on the cobas 6800/8800 Systems.