CERVISTA HPV HR
FDA premarket approval P080014/S002 · decided 2010-06-28
Approval details
- PMA number
- P080014
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERVISTA HPV HR
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2010-06-03
- Decision date
- 2010-06-28
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- NEW SUPPLIER OF BOVINE SERUM ALBUMIN (BSA), A RAW MATERIAL USED IN THE PRODUCTION OF ONE COMPONENT OF THE DEVICE.
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