CERVISTA HPV 16/18
FDA premarket approval P080015 · decided 2009-03-12
Approval details
- PMA number
- P080015
- Trade name
- CERVISTA HPV 16/18
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2008-04-28
- Decision date
- 2009-03-12
- Days to decision
- 318 days
- Decision code
- APWD
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR THECERVISTA HPV 16/18.CERVISTA HPV 16/18 INDICATIONS FOR USE:THE CERVISTA HPV 16/18 TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNA FROM HUMAN PAPILLOMAVIRUS (HPV) TYPE 16 AND TYPE 18 IN CERVICAL SPECIMENS.THE CERVISTA HPV 16/18 TEST USES THE INVADER CHEMISTRY, A SIGNAL AMPLIFICATION METHOD FORDETECTION OF SPECIFIC NUCLEIC ACID SEQUENCES. THIS METHOD USES TWO TYPES OF ISOTHERMAL REACTIONS:A PRIMARY REACTION THAT OCCURS ON THE TARGETED DNA SEQUENCE AND A SECO
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