CervistaTM HPV HR and GenfindTM DNA Extraction Kit

PMA Applicant:Third Wave Technologies

Address: Third Wave Technologies, Hologic, Inc. 502 South Rosa Road, Madison , WI 53719
Approval Date: March 12, 2009

These reagents are used with the Invader Call Reporter TM softwareto identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. If test results are positive, the patient is likely to be infected with HPV.

DNA is isolated from a scrape of cells from a woman’s cervix and is subsequently mixed in reaction wells with probes that specifically recognize HPV DNA. This reaction is detected by another substance that produces light, which is then measured to determine the presence of HPV in the cervical sample.

Visit : http://www.fda.gov/cdrh/mda/docs/P080014.html