PMA P100020S051
- Device
- cobas HPV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P100020
- Supplement
- S051
- Product code
- MAQ
- Decision date
- 2020-05-14
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Catalyst change in consumable pipette tip (CO-RE Tips with filter 1ml) for cobas HPV Test for use on the cobas 4800 System.
Current openFDA PMA Record#
- Device
- cobas HPV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P100020
- Supplement
- S051
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2020-05-14
- Decision code
- OK30
- Date received
- 2020-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Catalyst change in consumable pipette tip (CO-RE Tips with filter 1ml) for cobas HPV Test for use on the cobas 4800 System.