PMA P080015S013
- Device
- Cervista HPV 16/18 Assay
- Applicant
- Hologic, Inc.
- PMA number
- P080015
- Supplement
- S013
- Product code
- MAQ
- Decision date
- 2018-08-16
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Qualification of a new supplier and purchased raw material and updates to downstream manufacturing processes.
Current openFDA PMA Record#
- Device
- Cervista HPV 16/18 Assay
- Applicant
- Hologic, Inc.
- PMA number
- P080015
- Supplement
- S013
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2018-08-16
- Decision code
- OK30
- Date received
- 2018-07-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of a new supplier and purchased raw material and updates to downstream manufacturing processes.