Human papilloma virus IVDs

Intended purpose

The product HPV PLUS ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used by healthcare professionals as a qualitative multiplex nucleic acids Real-Time PCR assay for the detection and identification of the genomic DNA of Human Papilloma Virus 14 high-risk types as follow: detection and typing of the high-risk HPV 16, 18, 31, 45, detection of high-risk HPV HR1 group (33, 52, 58) and detection of high-risk HPV HR2 group, non-vaccinal types, (35, 39, 51, 56, 59, 66 and 68), extracted from clinical specimens. The product is intended for use as an aid in the diagnosis of HPV infections, in patients with cervical cytology or HPV molecular positive test results.