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™ software to identify DNA from human papillomavirus (HPV) types 16 and 18 in cervical samples. If test results are positive, the patient is likely to be infected with HPV type 16, 18 or both 16 and 18.
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 type 16 and 18 DNA. This reaction is detected by another substance that produces light, which is then measured to determine the presence of HPV type 16 and/or 18 in the cervical sample.
visit : http://www.fda.gov/cdrh/mda/
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