PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS

Primary DI

06975977071701

Basic UDI-DI Code

B-06975977071701

Reference

600170

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Gold Probe Diagnostic Biotechnology Inc. MF

Human Papilloma virus (HpV). belonging to the Papillomaviridae family is a small circularnon-enveloped, double-stranded DNA virus, with a genome length of about 8,000 base pairs(bp). HPV infection is very common in women. About 80% of women have been infected withHPY in their lifetime. and 90% of them can be naturally cleared within one to two years.Based on their oncogenic potential, HPVs are classified as low-risk. associated with benignwarts or epithelial lesions, or high-risk, that can cause oropharyngeal and anogenitalmalignancies, including cancers of the cervix, vulva, vagina, penis, and anus. High-risk HPY(hrHpV) types are responsible for -5% of all human cancers and are detected in 99.7% ofcervical cancer cases, the fourth most common cancer in women, accounting for 7.5% of acancer-associated deaths in women worldwide per vear. This kit is intended for the in-vitrogualitative detection of nucleic acids of 26 HPV types (16、18、31、33、35、 39、45、5152、56、58、59、68、26、53、66、73、82、6、11、40、42、43、44、54、81) incervical exfoliated cells.and genotyping for 26 HPV types.[EN]

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).