Device typeHuman papillomavirus (HPV) high-risk strain nucleic acid IVD, control: A material that is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen.
FDA categoryKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Device ID00884999048621
Catalog number09N15-085
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information