PMA P190028S022
- Device
- cobas® HPV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P190028
- Supplement
- S022
- Product code
- MAQ
- Decision date
- 2025-12-31
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- changes to QC testing of filters used in reagent manufacturing
Current openFDA PMA Record#
- Device
- cobas® HPV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P190028
- Supplement
- S022
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2025-12-31
- Decision code
- OK30
- Date received
- 2025-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to QC testing of filters used in reagent manufacturing