CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION
FDA premarket approval P080014/S007 · decided 2011-12-12
Approval details
- PMA number
- P080014
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2011-04-27
- Decision date
- 2011-12-12
- Days to decision
- 229 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- APPROVAL FOR MIGRATION OF THE CERVISTA HPV HR MANUAL ASSAY TO AN AUTOMATED PLATFORM HIGH-THROUGHPUT AUTOMATION. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER TRADE NAME CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION AND IS INDICATED FOR:THE CERVISTA HPV HR TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNA FROM 14 HIGH-RISK HUMAN PAPILLOMAVIRUS (HPV) TYPES (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, AND 68) IN CERVICAL SPECIMENS. THE CERVISTA HPV HR TEST CANNOT DETERMI
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