PMA P100020S063
- Device
- COBAS HPV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P100020
- Supplement
- S063
- Product code
- MAQ
- Decision date
- 2025-12-15
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- different in-process testing for manufacturing kit reagents
Current openFDA PMA Record#
- Device
- COBAS HPV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P100020
- Supplement
- S063
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2025-12-15
- Decision code
- OK30
- Date received
- 2025-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- different in-process testing for manufacturing kit reagents