DevicePMAs@therightstef:P890064_S021 11 Projects
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Approval for a trade name change for the hybrid capture 2 (hc2) high-riskhpv dna test and hybrid capture 2 (hc2) hpv dna test. the devices, as modified, will bemarketed under the trade name digene hybrid capture 2 (hc2) high-risk hpv dna test anddigene hybrid capture 2 (hc2) hpv dna test and are indicated for the qualitative detectionof specified types of human papillomavirus (hpv) dna in cervical specimens.
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