PMA P190028
- Device
- cobas® HPV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P190028
- Supplement
- S006
- Product code
- MAQ
- Decision date
- 2026-04-23
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval for extension of open kit stability for the cobas HPV from 90 days to 180 days.
Current openFDA PMA Record#
- Device
- cobas® HPV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P190028
- Supplement
- S024
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-04-23
- Decision code
- APPR
- Date received
- 2026-01-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extension of open kit stability for the cobas HPV from 90 days to 180 days.