PMA P080014S006
- Device
- CERVISTA HPV HR TEST
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S006
- Product code
- MAQ
- Decision date
- 2011-01-20
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- ADDITION OF AN ALTERNATIVE VENDOR FOR CERVISTA® HPV OLIGOS MIX 1, MIX 2, MIX 3 USED IN THE CERVISTA® HPV HR TEST.
Current openFDA PMA Record#
- Device
- CERVISTA HPV HR TEST
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S006
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2011-01-20
- Decision code
- OK30
- Date received
- 2010-12-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATIVE VENDOR FOR CERVISTA® HPV OLIGOS MIX 1, MIX 2, MIX 3 USED IN THE CERVISTA® HPV HR TEST.