PMA P080015S015
- Device
- Cervista HPV 16/18 Assay
- Applicant
- Hologic, Inc.
- PMA number
- P080015
- Supplement
- S015
- Product code
- MAQ
- Decision date
- 2018-10-09
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Transfer the purification and dilution operations for specified reagents within an existing manufacturing facility.
Current openFDA PMA Record#
- Device
- Cervista HPV 16/18 Assay
- Applicant
- Hologic, Inc.
- PMA number
- P080015
- Supplement
- S015
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2018-10-09
- Decision code
- OK30
- Date received
- 2018-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer the purification and dilution operations for specified reagents within an existing manufacturing facility.