CERVISTA HPV 16/18
FDA premarket approval P080015/S005 · decided 2011-08-02
Approval details
- PMA number
- P080015
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERVISTA HPV 16/18
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2011-07-07
- Decision date
- 2011-08-02
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- CHANGE IN THE STATISTICAL METHOD EMPLOYED DURING INCOMING MATERIAL INSPECTION OF THE HPV CONTROLS OF THE CERVISTA® HPV 16/18 AND REAGENTS IN THE GENFIND® DNA EXTRACTION KIT.
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