Device typeHuman papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials 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, using a nucleic acid technique (NAT).
FDA categoryKit, rna detection, human papillomavirus
Device ID15420045500129
Catalog number303231
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information