PMA P190028
- Device
- cobas HPV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P190028
- Supplement
- S006
- Product code
- MAQ
- Decision date
- 2026-06-16
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval for cobas HPV on the upgraded cobas 6800/8800 systems 2.0
Current openFDA PMA Record#
- Device
- cobas HPV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P190028
- Supplement
- S023
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-06-16
- Decision code
- APPR
- Date received
- 2026-01-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for cobas HPV on the upgraded cobas 6800/8800 systems 2.0